The Drug and
Cosmetic Act and
Jobin Kunjumon Vilapurathu
Grace college of Pharmacy
• Compilation of Drug and Cosmetic Acts 1940 and
• Passed with objective of regulating the import,
manufacture, sales and distribution and sale of
drugs and cosmetics.
• Acts and rules are amended from time to time, the
major amendment being made on 1982.
• Schedule M (GMP) and Schedule Y (CR) were
introduced in 1988.
• Main object of the act is to avoid substandard of
drugs in order to maintain high standard of medical
• Ayurveda Sidha and Unani Drugs:
o Include all medicines indented for internal or external use for or in diagnosis,
treatment, mitigation or prevention of disease or disorder in human beings or animals
& manufactured exclusively in accordance with the formulae prescribed in
authoritative books of Ayurvedic, sidha and Unani tibb systems of medicines.
• Central License approving authority:
o Means Drug Controller of India appointed by the Central Government.
o Includes a) all medicines used for the internal or external use of human beings or
animals and all substances indented to be used for or in diagnosis, treatment ,
mitigation or prevention of any disease or disorder in human beings or animals
including preparation applied for repelling mosquitoes b) substances indented to affect
the structure or any function of human body or indented to be used for the destruction
of vermin or insects that cause disease in human beings or animals c) all substances
indented for use as components of drug including empty gelatin capsules d) devices
indented for internal or external use in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human beings or animals.
o Include any process or part of process for making, altering, ornamenting, finishing,
packing labeling, breaking up or otherwise treating or adopting any drug or cosmetic
with a view to its sale or distribution but does not include the compounding or
dispensing of any drugs or packing of any cosmetics or drug in ordinary course of
• Patent or Proprietary Medicine:
o In relation to Ayurveda, Sidha or Unani systems of medicine all formulations containing
only such ingredients mentioned in the formulae described in authoritative books of
Ayurveda, Sidha or Unani Tibb systems of Medicine specified in the first schedule but
does not include medicine which is administered by parenteral route also formulations
included in authoritative books as mentioned in the first Schedule.
o In relation to any other system of medicine, a drug which is a remedy or prescription
presented in form ready for internal or external administration of human beings or
animals and which is not included in edition of the Indian Pharmacopoeia for the time
being or any Pharmacopoeia authorized in this behalf by the Central Government after
constitution with the DTAB.
• Misbranded drugs: A drug is deemed to be misbranded –
o If it is so colored, coated, powdered or polished that damage is concealed or if it is made
to appear of better or great therapeutic value than it really is.
o If it is not labeled in prescribed manner; or
o If its label or container or anything accompanying the drugs bears any statement,
design or device which makes any false claim for the drug or which is false or
misleading in any particular.
• Adulterated Drugs: A drug is deemed to be adulterated –
o If it consists in whole or in part, of any filthy, putrid or decomposed substance; or
o If it has been prepared, packed or stored under insanitary conditions whereby it may
have been rendered injurious to health; or
o If its container is composed in whole or in part, of any poisonous or delirious
substances which may render the contents injurious to health.
o If it bears for purpose of coloring only a color other than one which is prescribed.
o If it contains any harmful or toxic substance which may render it injurious to health; or
o If any substance has been mixed there with so as to reduce its quality or strength.
• Spurious Drugs: A drug is deemed to be spurious –
o If it is imported or manufactured under a name which belongs to another drug.; or
o If it is an imitation or is a substitute for, another drug or resembles another drug in a
manner likely to deceive or unless it is plainly and conspicuously marked so as to reveal
its true character and its lack of identity with such other drugs; or
o If the label or container bears the name of an individual or company purporting to be
the manufacture of the drug, which company or individual is fictious or does not exist.
o If it has been substituted wholly or in part by another drug or substance; or
o If it purports to be the product of a manufacturer of whom it is not truly a product.
• Misbranded Cosmetics: A cosmetic is deemed to be
o If it contains color which is not prescribe; or
o If it is not labeled in prescribed manner; or
o If the label or container of anything accompanying the cosmetic bears any statement
which is false or misleading in particular.
• Spurious Cosmetics: A cosmetic is deemed to be spurious –
o If it is imported under a name which belongs to another cosmetic; or
o If it is an imitation of, or a substitute for, or resembles another cosmetic in a manner
likely to deceive or bears upon it or upon its label or container the name of another
cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character
and its lack of identity with such other cosmetic; or
o If the label of the container bears the name of an individual or company purporting to
be the manufacturer of the cosmetic, which individual or company is fictitious and does
not exist; or
o If it purports to be the product of a manufacturer of whom it is not truly a product.
• Drug and Cosmetics Rules have been divided into 18 parts
each dealing with a particular subject. There are 2 schedules
to act and 26 schedules to Rules.
• First Schedule: Name of books under Ayurvedic Sidha and
Unani Tibb Systems.
• Second Schedule: Standard to be complied with by imported
drugs manufactured for sale, sold, stocked or exhibited for
sale or distributed. The Appendices prescribed are
o I – Data required to be submitted with application for permission to market a
o II – Format for submission of Clinical Trial Reports.
o III – Animal toxicity requirements for clinical trials and marketing of new
o IV – Number of animals for long term toxicity studies.
o V – Patient consent for participation in a Phase I Clinical trial.
o VI – Four groups of fixed dose combinations and their data requirements.
Important Schedules to rules
• A – Performa for application of licenses, issue and renewal of
licenses, for sending memoranda under the act.
• B – Rates of fee for test or analysis by the Central Drugs
Laboratory or the Government analyst.
• C – List of biologicals and special products whose import,
sale, distribution and manufacture are governed by special
• D – List of drugs exempted from the provisions of import of
• H – List of prescription drugs
• J – Diseases or ailments which a drug may not purport to
prevent or cure.
• K – Drugs exempted from certain provisions relating to the
manufacture of drugs
• M – Good Manufacturing Practices (GMP) requirements of factory
premises, plants and equipment's.
• N – List of minimum requirements of efficient running of
• P – life period of drugs.
• S – Standards of Cosmetics.
• T – Requirements of factory premises and hygienic conditions for
Ayurvedic and Unani drugs.
• U – Particulars to be shown in manufacturing, raw materials and
analytical records of cosmetics.
• V – Standards for patent or proprietary medicines.
• W – List of drugs to be marketed under generic names only.
• X – List of drugs whose import, manufacture and sale are governed
by special provisions.
• Y – Requirements and guidelines on Clinical Trials for import and
manufacture of new drugs.
Administration of the Acts and Rules
• For efficient administration of the acts and rules, the
following agencies have been provided:
o Drugs Technical Advisory Board (DTAB)
o Drugs Consultative Committee
o Central Drugs Laboratory
o Drugs Control Laboratories in States
o Government Analysis
o Licensing Authorities
o Controlling Authorities
o Drugs Inspectors
o Customs Collectors
Drugs Technical Advisory Board
• Constituted by Central Government to advise the Central and
State Governments on technical matters arising out of
administrations of the Act
• It consists of 18 members of whom 8 are ex-officio, 5
nominated and 5 elected members.
• Ex-officio members
o Director General of Health Sciences ( Chairman)
o Drugs Controller of India
o Director, Central Drugs Laboratory Calcutta
o Director Central Research Institute, Kasauli
o Director Indian Vetenary Research Institute, Izantnagar
o President, Pharmacy Council of India
o President, Medical Council of India
o Director, Central Drug Research Institute, Lucknow.
• Nominated Members
o 1) Two persons nominated by central Government from amongst persons who are in charge
of drugs control in states.
o 2) One person from Pharmaceutical Industry nominated by the Central Government.
o 3) Two Government Analysts, nominated by Central Government.
• Elected Members
o 1) A teacher in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an
Indian university or an affiliated college, elected by the Executive Committee of Pharmacy
Council of India.
o 2) A teacher in medicine or therapeutics on the staff of an Indian University or an affiliated
College, elected by the Executive Committee of PCI
o 3) One Pharmacologist elected by the Governing body of ICMR
o 4) One person elected by council of Central Medical Education
o 5) One person elected by Council of IPA.
• The nominated and elected members hold the office for three years but are
eligible for renomination and re-election.
• The Central Government appoints a Secretary and provides the clerical and
other staff to the board.
• The board may appoint sub-committees and may appoint persons who are not
board members either temporarily or for some period not exceeding 3 years.
The Central Drugs Laboratory
• Provides for the establishment of a Central Drugs Laboratory
under the control of a director appointed by Central
• The Laboratory established in Calcutta has been entrusted
with the following functions
o 1) to analyze or test samples of drugs or cosmetics sent to it by the cosmetics collectors
o 2) to carry out such other duties entrusted to it by the Central Government or with its
permission, by State Governments, after consultation with DTAB.
• The Central Research Institute, Kasauli carries out functions
in respect of sera, solutions of serum, proteins for injections,
vaccines, toxins, antigens, antitoxins, sterilized surgical
ligatures and sutures and Bacteriophages.
• Vetenary Research Institute, Izantnagar and Mukteshwar
carries out functions in respect of antisera, vaccines, toxoids
& diagnostic antigens, all for Vetenary Use.
• Samples of condoms are sent to Central Pharmacopoeial
• Samples of oral poliomyelitis vaccines are sent to Pasteur
Institute of India.
• Central Government has additional laboratories as reference
centers on AIDS.
• Functions in respect of all homeopathic medicines are carried
out at Homeopathic Pharmacopoeial Laboratory, Ghaziabad.
• Samples sent by courts for analysis or test to CDL should be
sent by registered post in a sealed packet, enclosed together
with memorandum in the prescribed form, in an outer cover
addressed to the Director. The package as well as outer cover
must be marked with a distinguishing number. A copy of
memorandum and specimen impression of the seal should be
sent separately to the Director by registered post.
• On receipt of the package, it should be opened by an officer
authorized in this behalf by the Director, who should record
the condition of the seal on the packet. Result of the test must
be sent to the sender Certificates issued must be signed by the
Director or any other officer authorized by the Central
Government in this behalf by notification in Official gazette.
The Drugs Consultative Committee (DCC)
• DCC is constituted by the Central Government in order to
secure uniformity in the Act throughout India.
• It is an advisory committee for the central and State
Governments and the DTAB.
• It consisted of two representatives nominated by the Central
Government and one nominee of each of the state
Governments. The committee meet when required by the
Central Government & is empowered to regulate its own
• State Government by notification in the Official Gazette,
appoint persons having sufficient qualifications to be
government Analysts for such areas in state & in respect of
such drugs and classes.
• Central Government may also similarly appoint Government
Analysts in respect of such drugs or classes of drugs or
cosmetics as specified.
• No person having any interest in the import, manufacture or
sale of drugs or cosmetics or is directly or indirectly engaged
in any trade or business connected with manufacture of
drugs can be appointed as Government analysts.
o A graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized
University and have 5 yrs post graduate experience in testing of drugs in a laboratory
under the control of 1)a Government Analyst or 2) head of approved Institution or
o A Post Graduate in medicine/science/pharmacy/pharmaceutical chemistry of
recognized University with at least 3 years of experience in the testing of drugs in a
laboratory under the control of 1)a Government Analyst or 2) head of approved
Institution or testing laboratory.
• Duties of Government Analyst
o Analyze or test samples of drugs/cosmetics sent to him by inspectors or other persons
under the act and to furnish reports of the results of test or analysis.
o Forward to Government from time to time, reports giving the results of analysis works
and research with a view to their publication at the discretion of Government.
o On receipt of package of sample from an Inspector the Government Analyst should
compare the seals on the package with the specimen seals and note its condition. On
completion of test, reports in triplicate together with full protocols of the tests or
analysis should be sent to the Investigator.
o Government Analyst has to submit a report in form 1 and unless full protocols are
supplied, the report cannot be regarded as conclusive evidence.
• Any application for the grand or renewal of license
for the import, manufacture, sale, distribution etc of
any drug or cosmetic is to be made to the LA. Drug
Controller, India has been notified as Central License
o He should be graduate in Pharmacy/Pharmaceutical Chemistry/Medicine with
specialization in Clinical Pharmacology/Microbiology from a recognized
o He has experienced in manufacture or testing of drugs or enforcement of the
provisions of act for a minimum period of 5 years.
• Drug Inspectors appointed under the act are
under the control of a controlling authority
o He should be graduate in Pharmacy/Pharmaceutical
Chemistry/Medicine with specialization in Clinical
Pharmacology/Microbiology from a recognized University; &
o He has experienced in manufacture or testing of drugs or
enforcement of the provisions of act for a minimum period of 5 years.
• Appointed by Central and State Governments.
• He should be a person with out any financial interest in the
import, manufacture or sale of drugs or cosmetics.
• They are deemed as public servants and are officially
subordinate to the Controlling Authority.
o For appointment as DI, person must have a degree in Pharmacy/Pharmaceutical
Chemistry/Medicine with specialization in Clinical Pharmacology/Microbiology from a
o For inspection of manufacture of substances in Schedule c, the DI must have 1) at least
18 months experience in manufacture of at least one of the substance specified in
schedule C 2) at least 18 month experience in testing one of the item in schedule C 3)
gained experience of NLT 3 yrs in inspection of firms manufacturing any of the
substances of Schedule C during their tenure as services as DI
• Powers of DI
o He can Inspect
• any premises wherein any drug or cosmetic is being
manufactured and the means employed for standardizing and
testing the drug or cosmetic;
• any premises wherein any drug or cosmetic is being sold, or
stocked or exhibited or offered for sale, or distributed ;
o Take samples of any drug or cosmetic
• which is being manufactured or being sold or is stocked or
exhibited or offered for sale, or is being distributed;
• from any person who is in the course of conveying, delivering or
preparing to deliver such drug or cosmetic to a purchaser or a
o At all reasonable times with necessary assistance
• search any person, who, he has reason to believe, has secreted
about his person, any drug or cosmetic in respect of which an
offence relating to manufacture sale or distribution has been, or is
being, committed; or
o enter and search any place in which he has reason to believe an
offence relating to manufacture, sale or distribution of drugs or
cosmetics has been, or is being committed; or
o stop and search any vehicle, vessel, or other conveyance which, he has
reason to believe, is being used for carrying any drug or cosmetic in
respect of which an offence has been, or is being, committed, and
order in writing the person in possession of the drug or cosmetic not
to dispose of any stock that of for a specified period not exceeding 20
days or, unless the alleged offence is such that the defect may be
removed by the possessor of the drug or cosmetic, seize the stock of
such drug or cosmetic and any substance or article by means of which
the offence has been ,or is being, committed
o examine any record, register, document or any other material object
with any person or in any place mentioned above and seize the same
if it is likely to furnish the evidence as an offence
o require any person to produce any record, register, or other document
relating require any person to produce any record, register, or other
document relating to the manufacture for sale or for distribution of
any drug or cosmetic n respect to which an offence has been
o exercise such other powers as may be necessary for carrying out the
purposes of the Acts or Rules.
• Duties of Inspectors
o A) Inspection of premises licensed for sale:
• Inspect NLT twice an year all establishments licensed for sale of drugs
within the area assigned to him and to satisfy himself that the
conditions of license are being observed.
• Procure and send for tests or analysis, if he has reason to think that
the drugs are sold in contravention of provisions of Acts or Rules.
• To investigate any complaints made to him in writing & to institute
prosecutions in respect to the braches of the act.
• To maintain all records of inspections made & actions taken by him
including taking of samples and seizure of stocks & to submit copies
of such records to the CA
• To make enquiries sand inspections as may be necessary to detect sale
of drugs in contravention to the Act.
• When so authorized by State Governments to obtain imported
packages which he has reason to suspect to contain drugs whose
import is prohibited.
o B) Inspection of Manufacture of Drugs
• Inspect NLT twice a year all premises licensed for the manufacture
of drugs within the area allotted to him and satisfy himself that
the condition of license and provisions of Acts and Rules are
• In establishments licensed to manufacture products specifies in
Schedule C and C1 inspect the process of manufacture, means
employed for standardizing and testing of drugs, methods & place
of storage, technical qualifications of staff employed & all details
of location, construction & administration of establishment likely
to affect the potency or purity of drug.
• To send controlling authority after each inspection a detailed
report indicating conditions of license & provisions of Acts & Rules
which are being observed & which are being not observed.
• To take samples of drugs manufactured on premises & send them
for test or analysis.
• To institute prosecutions in respect of breaches of Act and Rules.
• Procedure of Inspectors
o An Inspector taking any samples must pay its fair price & may require
written acknowledgement for the same. If price tendered is refused or
when Inspector seizes any stock of any drug or cosmetic, he should issue
the receipt for the same in prescribed form. (Form 16)
o He should inform the concerned person, the purpose of taking the sample
in form 17 & divide the sample to four parts In his presence. Each portion
is then sealed & suitably marked. The person from whom the sample is
taken must also be allowed to add his mark of seal on the packet. If
sample taken from a manufacturing premises, it should be divided to
three portions only.
o If the sample if made into small volume is likely to deteriorate, Inspector
can take three or more containers when necessary after suitably marking
o One portion of sample is to be restored to the person, second part send to
Government analyst and third one is preserved for production before the
court, if required & fourth is sent to warrantor if any.
o Inspector should sent sample to Government Analyst by registered post or
by hand in sealed packet enclosed together with memorandum in Form
18 in an outer cover addressed to Government analyst.
o If the confiscated drug is not of standard quality, it should be reported to
court accordingly & court may order destruction of drug under the
supervision of Inspector in presence of such authority that the court may
o If confiscated drug is of standard quality, Inspector may report court
accordingly and court may order sale of drugs by public auction to any party
holding a requisite license.
o Any record, register or any other document sized by the Inspector should be
returned to the persons from whom they where seized or who produce the
same within a period of 20 days of such seizure or produce.
o When an Inspector seizes any record, register or document, or any other
material object, he should as soon as inform the same to the judicial
magistrate & take his orders to the custody thereof.
o Every person for time being in charge of any premises where any drug or
cosmetic is manufactured or is kept for sale or distribution, on being required
by the Inspector is legally bound to disclose to the inspector the place where
drug or cosmetic is being manufactured or kept.
o Willfully obstructing the Inspector or refusing to provide any record or
register is punishable with imprisonment up to three years, or with fine or
• Good Manufacturing Practices (GMP)
• Guidelines are meant to assure the quality of drugs.
• Draft of GMP was prepared in 1975 & finalized &
implemented in 1988
• Part I deals with Good manufacturing practices
relating to factory premises.
• Part II deals with plant & equipment for the
manufacture of drugs.
• General Requirements
o Location of factory & its surroundings should ensure freedom from
contamination due to sewage drain, etc & obnoxious odors or fumes,
or large quantity of soot, dust or smoke.
o Factory building should be constructed to ensure production of drugs
under hygienic conditions.
o Operations such as manufacturing, processing, packing labeling &
testing should be carried out in such a way that mix up & cross
contamination are prevented.
o Premises should be constructed and maintained as to prevent entry of
insects & rodents, Interior surface should be smooth & free from
cracks & permit easy cleaning disinfection. Adequate lighting,
ventilation & humidity must be maintained. Drainage systems should
be underground, the sanitary fitting & electrical fixtures in the
manufacture area must be concealed. Water used must be free of
pathogenic micro organisms and of drinkable quality. Waste water
should be treated before disposal.
o There should be a validated system for the treatment of water so as to produce
purified water confirming to IP specification. Water should be stored in tanks
and freedom from microbial growth must be ensured. The tanks should be
cleaned periodically and the records should be maintained.
o Provisions should be made for the roper storage of the materials awaiting
disposal. The disposal of sewage and effluents shall be as required under the
Environmental Pollution control board while all biomedical waste must be
destroyed as per the rules of Biomedical Waste Management and Handling
• Warehousing Area
o Adequate areas shall be designed & provided with proper bins, racks &
platforms for the storage and warehousing of all materials & products,
machine & equipment's etc. Warehousing area must be clean, dry &
maintained within acceptable temperature limits. Storage areas should have
appropriate house keeping & rodents, pests & vermin control procedures &
records should be maintained.
o Active raw materials and excipients must require separate sampling and
o Regular checks should be made to ensure adequate steps taken against
spillage, breakage and leakage of containers.
• Production Area
o Should be designed to allow the production preferably in uni-flow &
with logical sequence of operations.
o The equipment's and materials must be placed orderly & the
movement of personnel must be restricted to avoid cross
o Separate dedicated self containing facilities should be made available
for the production of sensitive pharmaceutical products like penicillin
or biological preparations with live microorganisms.
o Pipe works, electrical fittings, ventilations, openings & similar service
lines must be designed to avoid creation of recesses.
o Service lines shall preferably identified by colors & nature of supply
and direction of flow shall be indicated.
• Quality control area
o Should be independent of production area & divided to separate
sections for physio-chemical, biological, microbiological & radio
o Laboratories shall be designed to avoid mix-ups and cross-
contamination. Separate instrument room with adequate area shall be
provided for sensitive & sophiscated instruments employed for
o Suitable storage space shall be provided for test samples, retained
samples, reference standards, reagents & records.
o Manufacture/testing shall be conducted under the direct supervision
of competent technical staff & head of quality control laboratory shall
be independent of manufacturing unit.
o Personnel in quality control and quality control operations shall be
suitably qualified & experienced & appropriate training must be given
to them in the duties & responsibilities assigned to them.
• Health, Clothing & Sanitation of workers
o All personnel coming to contact with products & raw materials should
be free from contagious diseases & should undergo periodic health
check up. Just before entry to manufacturing area, room with facility
for personnel cleanliness should be provided.
o Prior to employment, personnel shall undergo medical examination & shall be
free from TB, skin and other communicable/contagious diseases.
o Periodical medical examination at least once an year may be necessary.
o All persons prior to & during the employment shall be trained in practices
that ensure personnel hygiene.
o Persons handling beta lactam antibiotics shall be tested for penicillin
sensitivity before employment and those handling sex hormones, cytotoxic
substances & other potent drugs shall be periodically examined for adverse
o Direct contact shall be avoided b/w unprotected hands of personnel 7 raw
materials, intermediate, or finished unpacked products.
o All persons should wear clean body coverings.
o Smoking, eating, drinking, chewing or keeping plants or food & personnel
medicines shall not be permitted in production, laboratory storage & other
• Ancillary Areas
o Rest & refreshment rooms should be separate & should not lead directly to the
o Facilities for changing, storing of clothes & for washing & toilet purposes
should be provided and must be adequate for the number of users.
• Sanitation in Manufacturing premises:
o Manufacturing area should not be utilized for any other purposes & should
be maintained clear & in orderly manner free from accumulated waste, dust,
debris etc. A routine sanitation program must be exercised.
o Production areas shall be well lit, particularly where visual online controls
are carried out.
• Raw Materials: All raw materials must be
o Purchased from approved sources under valid purchase vouchers, possibly
from producers directly.
o Identified & their containers examined for damage& assigned control number.
o Identified & their containers examined for damage& assigned control number.
o There shall be separate areas for materials under test, approved & rejected.
o All incoming materials shall be quarantined immediately after receipt or
o Materials must be stored in such a way that first in/first expiry, first out
principle can be applied.
o Only raw materials released by QC department & which are within their shelf
life shall be used.
• Sterile Products
o Separate enclosed areas provided with air locks, dust free, ventilated with air
supply through HEPA filters are recommended.
o Routine microbial counts of area are necessary during manufacturing
o Design of area must avoid possibility of mix up between sterile & non sterile
o Access to manufacturing area must be restricted to authorized personnel only.
• Working Space
o Adequate working space 7 adequate room for orderly placement of
equipment & materials should be provided to eliminate mix up between
different drugs 7 cross contamination.
o Separate space should be provided in storage area for “under test”, “approved”,
and “rejected”, materials.
• Medical Services: Manufacturer must provide
o Adequate facilities for first aid.
o Medical examination of workers at time of employment & periodic check up
there after once in a year.
o Facilities for vaccination or other exigencies.
• Equipment: Equipment used for manufacture must be
constructed, designed, installed & maintained to
o Achieve operational efficiency to attain the desired quality.
o Prevent physical, chemical or physiochemical change through surface
o Prevent contact of any substances required for operation of equipment's such
o Facilitate thorough cleaning whenever necessary.
o Minimize any contamination of any drugs and their containers during
• Master Formula Records: The Licensee ‘d maintain master formula records
relating to all manufacturing procedures for each product. The master
formula record shall give
o Patent or proprietary name of product along with generic name.
strength & dosage form
o Description or identification of final containers, packaging materials.
Labels & closures to be used.
o Identity, quality & quantity of each raw materials to be used.
o Description of all equipment's & vessels & the size used in the process.
o Manufacturing & control instructions along with parameters for
critical steps such as mixing, drying, blending, sieving, sterilizing the
o Theoretical yield to be expected from the formulation
o Detailed instructions & precautions to be taken in manufacture,
storage of drugs & of semi-finished products & the requirements in
process quality control tests & analysis to be carried out during each
stage of manufacture.
• Batch Manufacturing Records: Licensee ‘d maintain batch manufacturing
records for each batch of drugs as per Schedule U. it ‘d provide complete
account of manufacturing history of each batch showing that it has been
manufactured, tested & analyzed in accordance with manufacturing
procedures & written instructions as per master formulae.
• Manufacturing Operations & Control: All manufacturing operations must
be carried out under the supervision of competent technical staff. Critical
steps in the process related to selection, weighing & measuring of raw
materials must be done under the direct supervision of competent
• Product containers & closures: ‘d comply with Pharmacopoeial
requirements. Suitable test methods, cleaning & sterilization procedures ‘d
be used to assure that components, closures & other component part of
drug packages are suitable & they are not reactive, additive, absorptive,
adsorptive or leach to an extent that significantly affects the quality or
purity of the drug.
• Labels & other printed materials: Printed labels & packaging materials
including leaflets ‘d be handles & accounted to ensure that they don not
become intermixed. Prior to issue, they should be examined & released as
satisfactory for use by quality control personnel.
• Distribution of Records: Records for the distribution of each batch of drug
should be maintained in order to facilitate prompt & complete recall of the
batch if necessary.
• Quality control system: Principal duties of quality control department are.
o Prepared detailed Instruction for carrying out each tests & analysis.
o To release or reject i) each batch of raw material, ii) semi-finished
products if necessary, iii) packaging & labeling materials & final
containers, iv) each batch of finished products ready for distribution.
o Evaluate adequacy of conditions under which raw materials, semi-
finished products & finished products are stored.
o Evaluate quality & stability of finished products.
o To establish, & when necessary revise, control procedures & specifications.
o To examine returned products as to whether such products ‘d be released,
reprocessed or destroyed.
Schedule M Part II
Plant & Equipment
• Recommends the requirements of plant & equipment for the manufacture
of drugs under the following sections.
o i) Ointments, emulsions, lotions & suspensions, ii) syrups, elixirs &
solutions, iii)pills, compressed tablets & hypodermic needles, iv)
Powders, v) Hard gelatin capsules, vi) surgical dressings other than
absorbent cotton, vii) Eye ointments,, eye lotions & other preparations
for external use, viii) pessaries & suppositories, ix) inhalers, x)
repacking of drugs, xi) Parenteral preparations.
MANUFACTURE OF DRUGS
• Manufacture in relation to any drug or cosmetic, includes any process or
part of process for making, altering, ornamenting, finishing, packing,
labeling, braking up or otherwise treating any drug or cosmetic with a
view to its sale & distribution but does not include the compounding or
dispensing of any drug or packing of any drug in ordinary course of retail
• Following licenses are provided for manufacture of drugs under D&C Act
1. Drugs other than those specified in Schedule C, C1 & X
2. Drugs specified in Schedule C, C1 but not specified in Schedule X
3. Drugs specified in Schedule C, & C1
4. Drugs specific in Schedule X but not in Schedule C & C1
5. Drugs specified in Schedule C, C1 and X
6. Drugs for the purpose of examination, test or analysis
7. Loan Licenses
8. Repacking Licenses
9. Blood products
• Repacking is also a manufacturing for the purpose of the act.
• If drugs are manufactured in more than one set of premises, a
separate application is to be made & separate license shall be
issued in respect of each such premises.
• Licenses for manufacture or sale or distribution of drugs are
granted or renewed by Central License Approving Authority
(CLAA) appointed by the central government.
• CLAA can delegate his power of signing licenses to any other
person under his control with approval of the Central
Prohibition for the manufacture & sale of
• From the date notified by the State Government, no person
shall himself manufacture for sale or distribution or sell or
o Any drug which is not of standard quality or is misbranded, adulterated or
o Any cosmetic which not of standard quality or is misbranded, adulterated or
o Any patent or proprietary medicine whose formulae is not disclosed on label
or the container;
o Any drug which purports to cure, mitigate or prevent any disease specified in
o Any cosmetic containing any ingredient which may render it unsafe or
harmful for use;
o Any drug or cosmetic in contravention of this act or rules thereunder;
o Any drug or cosmetic which has been imported or manufactured in
contravention of the provisions of this Act or Rules thereunder or in
contravention of the conditions of a license.
• Every person not being manufacturer of a drug or cosmetic or his agent
for the distribution shall if so required disclose to the inspector the name
address and other particulars of the person from whom he procured the
drug or cosmetic.
• A drug or cosmetic shall not be rendered to be misbranded, adulterated or
spurious or below standard quality, if-
o There has been added thereto some innocuous substance or ingredient
required for its manufacture or preparation as an article of commerce in state
fit for carriage or consumption, & not to increase the bulk, or weight or
measure of the drug or cosmetic or to conceal its inferior quality or other
o In process of manufacture, preparation or conveyance some extraneous
substance has been unavoidably become inter-mixed with it, however this
does not apply in relation to any sale or distribution of the drug or cosmetic
occurring after the vendor or distributor becomes aware of such inter-
• There are two types of conditions for all manufacturing
o Conditions which are to be satisfied before a license is granted
o Conditions which are to be satisfied after the license is granted.
Manufacture of drugs specified in
Schedule C, C1 & X
• Application for the license of manufacturing drugs specified in Schedule
C, C1 excluding those specified in Schedule X should be made to the LA or
CLAA in Form 27 & for manufacture of drugs specified in Schedule C. C1
& X in for 27B. Respective licenses are issued in Form 28 & 28B.
• Application for including any additional drug in the license should be
accompanied by a fee of Rs.50 for each drug subject to a maximum of
• Conditions for the grant of license: Before the grand of license, the
following conditions must be complied by the applicant
1. The manufacture will be conducted under the active direction of a competent technical
staff consisting at least one person who is a full time employee & who is
• A graduate in pharmacy/pharmaceutical chemistry of a recognized University
with al least 18 months practical experience after graduation in manufacture of
drugs to which this license applies.
• A graduate in science of a recognized University who passed in degree with
chemistry or microbiology as principal subject & had al least 3 years experience in
the manufacture of drugs to which the license applies.
• A graduate in medicine of a recognized University with at least 3 years experience
in manufacture of relevant drugs; or
• A graduate in chemical engineering of a recognized University with at least 3
years experience in manufacture of relevant drugs; or
• Holding any foreign qualification comparable in quality, content and training with
above qualifications & is permitted to work as competent staff by Central
2. The factory conditions must comply with the conditions prescribed in
Schedule M and M3
3. Applicant should provide adequate space, plant & equipment for any or all
manufacturing operations as prescribed in Schedule M & M3
4.Applicant should provide adequate staff, premises and laboratory equipment
for carrying out such tests for strength, quality & purity of substances as
required under the rules.
5. Adequate facilities for the storage of manufactured drugs should be provided.
6. Data on stability of drugs that may deteriorate, for fixing the date of expiry
shall be furnished to LA.
7. Licensee shall comply with requirements of GMP.
8. For manufacture of patent or proprietary medicines, data should be provided
to LA that justifies that the medicines are
are stable under conditions of recommended storage.
contains such ingredients & in such quantities for which there is therapeutic
• License in form 28 & 28B remains valid for a period of 5
years on and from the date on which it is issued.
• If application for renewal is made before its expiry, or
application made within 6 months of expiry, after payment of
additional fee, the license shall continue to be valid
• License shall deemed to have expired if the application for its
renewal is not made within 6 months of its expiry.
• Large Volume Parenteral means the sterile solutions indented
for parenteral administration with a volume of 100ml or
more in one container of the finished dosage form indented
for single usage.
• Conditions of the License
1. Licensee should provide & maintain, adequate staff & adequate premises and plant for
the proper manufacture & storage of substances
2. Licensee ‘d maintain records of the manufacture as per particulars given in schedule
3. Licensee ‘d allow Inspectors to enter any premises where manufacture is carried on &
to inspect the process of the manufacture.
4. Licensee ;d allow inspectors to inspect all registers and records maintained under these
rules & to take samples of manufactured product
5. ‘d inspect LA any changes in expert staff & any material changes in premises or plant
since date of last inspection.
6. On request by LA licensee ‘d furnish form every batch, a sample of adequate quantity
for any examination
7. If any batch has been found out by LA not to confirm with the standards, licensee ‘d
withdraw the remainder of batch from sale.
8. ‘d maintain a Inspection book to enable inspector to record his impression.
9. ‘d maintain reference samples of each batch of drugs manufactured by him, in a
quantity twice than that sufficient for conducting all tests.
10. ‘d forward to LA of state a statement of sales effected to manufacturers, wholesalers,
retailers, hospitals, nursing homes, dispensaries every three months.
Manufacture of Drugs other than
those specified in Schedule C & C1
• Application for the grand or renewal of license for the manufacture of
drugs other than those specified in schedule C, c1 & X ‘d be made to LA in
Form 24 & for manufacture of Schedule X drugs in Form 24F. Respective
licenses are issued in form 25 & 25F
• Application for grand/renewal of such license shall be made for up to 10
items in each category in Form 24-A accompanied by fee of 6000 & an
inspection fee of Rs. 1500 to LA & license shall be issued in Form 25A.
• Additional fee of Rs 300 per item is payable for each additional item
• License in form 25 or 25F remains valid for a period of 5 years on and
from the date on which it is issued.
• If application for renewal is made before its expiry, or application made
within 6 months of expiry, after payment of additional fee, the license
shall continue to be valid
• License shall deemed to have expired if the application for its renewal is
not made within 6 months of its expiry.
Manufacture of Drugs for
Examination, Tests or Analysis
• License is necessary for the manufacture of any drug in small
quantity for the purpose of examination, test or analysis.
• If a person proposing to manufacture does not hold license i) to
manufacture drugs other than those specified in Schedule C, C1 &
X, or ii) to manufacture drugs specified in Schedule C, C1 in respect
to such drugs; he should obtain license in Form 29.
• If drug is not recognized as safe for use, license in Form 29 is only
granted after producing no objection certificate from LA appointed
by Central Government.
• License remains valid for a period of one year time
• Drugs ‘d be kept in containers bearing labels indicating the
purpose for which it has been manufactured.
• If the drugs are to be supplied, it should bear label stating name &
address of manufacturer, scientific name of substance & purpose
for which it has been manufactured.
• Conditions for License
1. Drugs ‘d be used exclusively for the purpose for which
they are manufactured
2. Licensee ‘d allow inspector to inspect the premises &
satisfy himself that only examination, test or analysis is
3. Licensee ‘d keep record of quantity of drugs
manufactured and supplied to any person.
4. Licensee ‘d maintain inspection book to enable inspector
to record his impression and defects noticed.
5. Licensee must comply with any rules made subsequently
and of which the LA has given him NLT one months
Manufacture of New Drugs
• Defined as a drug the composition of which is such that it is
not generally recognized among experts as safe for use under
conditions recommended; or
• suggested on the label & includes any drug the composition
of which is such that the drug as a result of investigations for
determining its safety for use under such conditions, is so
recognized but which has not otherwise than during course
of such investigations, been used to any large extend for any
appreciable length of time under the said conditions.
• Provisions applicable for the manufacture of new drugs
whether classifiable under schedule C & C1 or otherwise:
o No new drug can be manufactured unless prior approval of the LA has been
o Applicant ‘d produce all documentary & other evidence relating to the
standards of quality, purity, strength & such other information as may be
required including the results of therapeutic trials carried out on the new
o While applying for a license to manufacture a new drug, or its preparations
an applicant should produce along with his application evidence that the
drug has already been approved.
Loan Licenses• A loan license means a license which a LA may issue to a applicant who does
not have his own arrangements for manufacture but who intends to avail
himself of the manufacturing facilities owned by another licensee.
• Issued for the manufacture for sale or distribution of drugs other than those
specified in Schedule C, C1 & X.
• Application for license is made in Form 24-A & the license is issued in Form
• Before grant of license, the LA or CLAA shall get the premises inspected by one
or more inspectors.
• Inspector shall check into all the portions of the plant & shall also inquire in
professional qualification for the technical staff employed.
• For the manufacturing of additional items, an application must be made to LA.
• Licensee is required to test each batch of raw materials & finished products &
the records must be maintained for a period of 5 yrs from the date of
manufacture. (2yrs in case of drugs having expiry date, from the date of
• Loan license is deemed to be cancelled or suspended if license owned by loan
licensee, whose manufacturing facilities is been availed by licensee is
cancelled or suspended.
• Repacking license are granted for breaking up of any drug other
than those specified in Schedule C, & C1, on application to LA in
Form 24B & license is issued in Form25B subject to satisfying the
1. The repacking operation must be carried out under hygienic
conditions & under supervision of competent staff namely,
a) A person who holds an approved Diploma in Pharmacy or is an Registered
b) A person who has passed intermediate examination with Chemistry as principal
c) A person who has passed matriculation & has at least 4 yrs practical experience in
manufacturing, dispensing or repacking of drugs.
2. Factory conditions must specify conditions prescribed in Schedule
3. Applicant must have in his premises adequate facilities for the
testing of drugs. Which is separate from the repacking unit.
4. License must be kept at licensed premises & produced on request
5. Any change in competent staff must be reported to LA
6. For repacking of any additional items, application must be
made to LA.
7. The label on repacked drugs should mention the name &
address of the licensee & his license number preceded by the
word ‘Rpg. Lic. No.”
8. The license remains valid up to 31st December of the year
following the year in which it is grated.
Import & Registration of
Drug & Cosmetic
• Drugs/cosmetics may be imported to India under the
authority of a license excepting those whose import is
• Some drugs/cosmetics can be imported without any permit,
providing they are of standard quality & statement that they
comply with the provisions relating to import has been given
to the Customs Collector by manufacturer or importer.
o Requirement of registration of premises & drugs manufactured & meant for
the import to India was introduced with effect from 1.1.2003
• Registration Certificate means a certificate issued by the LA
for the registration of premises & drugs manufactured by the
manufacturer meant for import into & use in India.
• An application for the issue of a registration certificate should
be made to LA along with the information & undertaking
specified in Schedule DI & DII. Registration certificate
remains valid for a period of 3 years.
• Requirements of Schedule D I are as follows
I. Particulars of manufacturer & manufacturing premises- i) name & address
of manufacturing premises to be registered. Ii) name & address of
partners/directors iii) name & address of authorized agents in India. Iv) brief
profile of manufacturer’s business & research activity v) copy of plant
master file. vi) copy of plant registration/approval issued by authority of
concerned foreign country.
2. Particulars of manufactured drugs to be registered under registration
certificate- i) name of drug to be registered for import into & use in India.
ii) a copy of approval list of above drugs showing permission for
manufacturing/marketing in the country of origin. iii) a copy of GMP
certificates as per WHO guidelines. iv) domestic prices of drugs to be
imported in the currency of country of origin, v) names of drugs which
are original products of the manufacturer.
3. Undertaking to declare that- i) that applicant shall comply with the
conditions imposed under acts & rules, ii) applicant report from time to
time any changes pertaining registration certificate or any administrative
action taken due to ADR, iii) applicant shall allow LA to enter & inspect
manufacturing premises & to examine process r procedures & allow to
take samples of drugs concerned for test, analysis or examination, in
respect to any drug manufactured for which application for registration
certificate has been made.
• The requirements of Schedule D II are as follows
1. General- i) name of drug/formulation/special product, a brief description,
therapeutic class to which it belongs, Drug Masters file & GMP certificate, ii)
list of countries where marketing authorization for said drug is
granted/cancelled/withdrawn/pending, iii) list of countries where said drug
is patented & iv) domestic price of drug n currency followed in country of
2. Chemical & Pharmaceutical Information of the drugs- i) chemical name,
dosage form, composition, source, specifications & tests for identification of
active ingredients, iii) documentation on pack size, storage condition, safety
documents on containers & closures, iv) manner of labeling & package insert,
v)three samples of drug/product & outer packing with batch certificate to be
submitted, vi) batch test reports of five consecutive production batches to
submitted for every site of manufacturing.
3. Biological & Biopharmaceutical information of drugs- i) biological control
tests applied on starting material/intermediate products/finished products, ii)
stability of finished product, iii) sterility & pyrogen test specification &
protocol designs, iv) acute & sub acute toxicity test & specification & protocol,
v) date relating to bioavailability studies & bio equivalence, vi) any other
4. Pharmacological & toxicological information of drugs- i) executive
summary of product mentioning specific & general pharmacologic actions of
drug & pharmacokinetic studies, ii) note on acute, sub acute & long term
toxicity studies & details on specific studies on reproductive toxicity, local
toxicity & carcinogenic studies.
5. Clinical Documentation- separate permission for new drug (under rule
122E) by LA is required & such new drugs requires a brief summary on
clinical documentation along with necessary permission for its registration
6. Labeling & packaging information of drugs- i) labels should as per
specification under the acts & rules, ii) package inserts ‘d be in English &
include following therapeutic indications: posology & method of
administration, contraindications, special warnings & special precautions,
interactions, whether pregnancy & lactation contraindicated, undesirable
effects, antidote for over poisoning, effects on ability to drive & use machines,
iii) package insert ‘d include information on list of exepients,
incompatibilities, shelf life, special precautions for storage, name &
specification of the container & instruction for use/handling.
7. Specific information for special products- to be supplied separately in
annexures A,B & C.
Prohibition of Import of certain
drugs or cosmetics
• No person can import
1. Any drug/cosmetic which is not of standard quality
2. Any misbranded, spurious or adulterated drug
3. Any misbranded or spurious cosmetic
4. Any drug/cosmetic for import for which license is prescribed otherwise than under &
in accordance with such license.
5. Any patent or proprietary medicine unless there is displayed in the prescribed manner
on the label the true formulae or list of active ingredients in it.
6. Any drugs which purports to claim or mitigate any such disease or ailment specified in
schedule j in the rules
7. Any cosmetic which contains an ingredient which may render it unsafe for use.
8. Drugs whose manufacture sale & distribution are prohibited in the country of origin,
9. Drugs not labeled & packed in prescribed manner
10. Biologicals & other special products after the date of their expiry as mentioned in label
or those not complying with the standards of strength, quality, purity as may be
11. Any new drug expect with express permission of licensing authority.
12. Any drug/cosmetic, the import which is prohibited under the rules.
Import of Drugs under License or Permit
• The following classes of drugs can be imported under the
license or permit granted by LA
1. Drugs specified in Schedule C C1 except those specified in Schedule X
2. Drugs specified in Schedule X
3. Small quantities of drugs imported for the purpose of examination, test or
4. Drugs for personal use covered by the prescription of registered medical
5. Any new drug
An application for import license must be made to the proper
authority in prescribed form & license remains valid up to 31st
December of the year following the year it was granted unless it
was suspended earlier.
Aggrieved party has the right to appeal in High Court against
an order of the drugs controller of India canceling the import
license granted to him.
• A separate license is necessary in respect of drugs from each
• A separate license is necessary in respect to drug
manufactured in each premises when a single manufacturer
abroad has more than one factory.
• A single application may be made & single license may be
issued in respect of import of more than one drug or class of
drugs manufactured by same manufacturer.
• A change in constitution of licensed firm must be informed to
Conditions of Import License
• An import license is subjected to the following conditions
1. Manufacturer must observe at all times the undertaking given by him or on
his behalf on Form 9.
2. The license must allow any authorized inspector to enter any premises where
the imported substance is stocked to inspect the means, if any, employed for
testing the substances 7 to take samples.
3. The licensee should furnish a sample adequate for examination as required
by LA together with full protocol for tests if any from all batches or from
such batches as directed by LA.
4. If directed y LA the licensee ‘d not sell any batch in respect of which a sample
or protocols are furnished as above until certificate is issued to him by LA.
5. In case the licensee is informed by LA that the drug does not comply with the
prescribed standard, he ‘d recall the entire batch from market as practicable.
6. ‘d maintain records of all sales of imported substances showing particulars of
substances & persons to whom it is sold & such records must be open for
7. ‘d comply with further requirement as may be prescribed by LA & which has
been given NLT 4 months notice
• Import of fixed dose combinations
o Application for import or manufacture of fixed dose combination of
two or more drugs shall be made to the LA. LA after satisfied that the
fixed dose combination to be imported shall be effective & safe for use
in country shall issue permission in form 45 or Form 46.
• Import of Schedule C, C1 & X drugs
o An import license is required for the import of any biological or other
special product specified in schedules C, C1 excluding X, & drugs
specified in Schedule X. LA must also be satisfied that the premises
where imported substance will be stocked by the importer are
equipped with proper storage accommodation for preserving the
properties of imported drugs. Licensee ‘d inform LA any change in the
constitution of licensed firm.
• Import of drugs for examination, test or
analysis: small quantities of drugs can be imported
subject to the following conditions—
1. Drugs can be imported only under a license in Form 11
2. Substances imported ;s be used exclusively for the purpose of
examination, test or analysis in the place specified or in any other
place authorized by LA.
3. Licensee must allow any authorized inspector to enter & inspect the
premises & to investigate the manner in which the substances are
being used & to take samples thereof.
4. Licensee must keep record of samples imported under the license
together with their quantities, date of importation &name of
manufacturer, & report these particulars to the LA.
5. Licensee must comply with any further requirement & of which LA
has given him NLT one months notice.
Import of Drugs for Personal Use: Drugs whose import is otherwise
permitted may be imported in small quantities subject to the following
1. Drugs must form part of a passengers bonafide baggage & must be indented
exclusively for the personal use of passenger.
2. Drug must be declared to the Customs Collector, if so directed,
3. The quantity of any single drug so imported must not exceed hundred
LA may in exceptional cases sanction the import of larger quantities.
Import of drugs by Govt. Hospitals/Medical Institutions for the
treatment of patients:
Small quantities of new drugs otherwise prohibited for import may
be imported for the treatment of patients suffering from life-threatening
diseases or diseases causing serious or permanent disability by a medical
officer of Govt. Hospital or Medical Institution. Application for such import
must be made in Form 12AA.
• Import of New Drugs:
o No new drug can be imported except with the permission of the LA. While
applying for such permission, all documentary & other evidence relating to
standards of quality, purity & strength ‘d be supplied to the LA.
• Procedure for Import of New Drugs:
o The drugs ‘d be labeled in conformity with the prescribed rules. All
consignments of drugs to be imported ‘d be accompanied by an invoice or
other statement showing the make & address of the manufacturer & the
names & quantities of the drugs. Before importing such drugs, declaration
signed by the manufacturer on behalf of the importer that the drugs comply
with the provisions of the Acts & Rules ‘d be supplied to the customs collector.
o Customs Collector can take samples of any drugs in the consignment &
forward to the director of laboratory appointed for this purpose by the
Central Government. If report of analysis indicate that the drug in a
consignment is not of standard quality the Customs Collector may direct the
imported to export back the consignment to the manufacturer within two
months or forfeit the same to Central Government for destruction.
Exempted Drugs: the drugs specified in Schedule D are
exempted from provisions of import of drugs as follows
Class of drugs Extend of Conditions of
• Substances not indented for medicinal use
• Substances used both as drugs as well as
food, eg: condensed or powdered milk,
Farex, Oats, Lactose & similar Cereal
preparations whether fortified with
Vitamins or otherwise excepting those for
• Virol, brovil, Chicken essence & all other
similar predigested foods
• Ginger, pepper, cumin, cinnamon &
similar spices & condiments of official
• Drugs & Cosmetics imported for
manufacture & export by Units situated in
special Economic zones as notified by
Government of India in time to time.
• Can be imported without any restriction
provided imported in bulk & label
indicating that substance is not indented
for medicinal use
• Exempted from all provisions regulating
• Can be imported without restriction
provided covered by an import license,
import registration && imported through
notified port of entry, subject to conditions
that these drugs & cosmetics shall not the
diverted for sale in the Country
Places through which drugs may be imported in India
• In respect to drugs
imported by rail across the
frontier with Pakistan
• In respect to drugs
imported by rail across the
frontier with Bangladesh
• In respect to drugs
imported by road & rail
connecting India & Nepal
• In respect to drugs
imported by sea into India
• In respect to drugs
imported by air into India
• Ferozpur cantonment &
Amritsar Railway station
• Ranaghat, Bongaon &
Mohiassan Railway Stations
• Chennai, Kolkata, Mumbai,
Cochin & Kandla
• Chennai, Kolkata, Mumbai,
Delhi, Ahmedabad &
Offences Relating to Import of Drugs
• Import of adulterated or spurious drugs/cosmetics or
cosmetics containing substances which may render it unsafe
or harmful for use
o First Conviction: Imprisonment up to three years & fine up to 5000
o Subsequent Conviction: Imprisonment up to five years or fine up to 10,000 or
• Import of any drugs or cosmetics other than referred above,
the import of which is prohibited
o First Conviction: Imprisonment up to 6 months or fine up to 500 or both
o Subsequent Conviction: Imprisonment up to one year or fine up to 1000 or
• Import of any drug or cosmetic in contravention of any
notification issued under section 10A
o Imprisonment up to three years or fine up to 5000 or both.
Application of laws relating to
Sea & customs
• The Customs Collector & other Officers authorized in this
behalf by the Central Government may detain any imported
packages which he suspects to contain any drug or cosmetic
the import of which is prohibited under this act, and report
such detention to the drugs Controller, India & if necessary
forward any package or sample to Central Drugs Laboratory