It contains the latest amendments (2015-2018) of the Drugs and Cosmetics act

1. LATEST AMENDMENTS
OF THE D&C ACT
PRESENTED BY,
AKHILA PAUL
IST M.PHARMACY (PRA)

2. CONTENTS
 INTO THE HISTORY OF D&C ACT
 OBJECTIVES OF D&C ACT
 ADMINISTRATION AUTHORITIES
 AMENDMENTS:
 2015
 2016
 2017
 2018

3. INTO THE HISTORY……
 During first quarter of 1900s, an agitation towards substandard
medicines was raised by the medical professionals of those days, who
brought the issue to the notice of ‘Council of States’ in 1927.
 Consecutive to this, the Government appointed a ‘Drug Enquiry
Committee’ under the Chairmanship of Lt. Col. RN Chopra in 1930,
which recommended the formation of a ‘Central Legislation’ for setting
up of suitable standards.
 Based on these recommendations, Government has introduced ‘Import
of Drugs Bill’ in Legislative Assembly in August 1937.
 The act was finally passed on April 10th 1940 as the ‘DRUGS ACT
1940’

4.  The scope of the Drugs Act was extended to cosmetics in 1962 and
the title of the act was changed to ‘Drugs & Cosmetics Act’.
 The drugs belonging to the systems of Ayurveda, Siddha and Unani
(ASU) Systems were brought within the purview of the D & C Act in
1964.
 Schedule M (GMP) and Schedule Y (CR) were introduced in 1988.

5. OBJECTIVES OF THE ACT
 To regulate the import, manufacture, distribution and sale of drugs &
cosmetics through licensing.
 Manufacture, distribution and sale of drugs and cosmetics by
qualified persons only.
 To prevent substandard in drugs.
 To regulate the manufacture and sale of Ayurvedic, Siddha and
Unani drugs.
 To establish Drugs Technical Advisory Board(DTAB) and Drugs
Consultative Committees(DCC) for Allopathic drugs and cosmetics.

6. ADMINISTRATION AUTHORITIES
 A) Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-D.C.C.
 B) Analytical :
1)Central Drugs Laboratory - CDL
2)Drug Control Laboratory in states
3)Government Analysts
 C) Executives :
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors

9. AMENDMENTS OF 2015
 GSR 68E drafted on 3 February, 2015
 Powers conferred by the section 12 and 33
 In rule 71(Conditions for the grant or renewal of a license), after
sub rule 6 the following shall be inserted namely:
“The applicant shall while applying for the license to manufacture the
drugs, furnished to the Licensing Authority evidence and data
justifying that the drugs are stable for the proposed shelf life under the
condition of storage recommended and the data shall be generated as
per Appendix IX of Schedule Y”
...DocumentsD&C_Rules_Schedule_Y.pdf

10.  GSR 69E dated 3 February, 2015
 In rule 122 DA(Application for permission to conduct clinical
trials for New Drug/Investigational New Drug) the following
‘EXPLANATIONS’ shall be substituted:
 ‘CLINICAL TRIALS’ means a systematic study of any new drug in
human subjects to generate data for discovering or verifying the
clinical, pharmacological or adverse effects with the objective of
determining safety or efficacy of the new drug’.
 ‘GLOBAL CLINICAL TRIAL’ means any clinical trial which is
conducted as part of multi-national clinical development of a drug.
 ‘INVESTIGATIONAL NEW DRUG’ means a chemical entity or product
having therapeutic indication but which never have been tested earlier
on human being.
 ‘NEW CHEMICAL ENTITY’ means an active substance in
developmental stage which may be specified as a drug under the act.

11.  GSR 289E dated on April 15, 2015
 In rule 74,(Conditions of license ) the following shall be inserted
namely,
‘No advertisement of the drugs specified in the Schedule H, H1 and
X shall be made except with the previous sanction of the central
government’.
 GSR 449E, 3 June,2015
 In rule 96, (Manner of Labeling), the following shall be inserted,
‘The manufacturers of the drug formulations shall print the details
specified below to facilitate the tracking and tracing of the product.
1. At primary level packing two dimensional barcode encoding unique
and universal global product identification code in the 14 digits
Global Trade Item Number format.
2. At secondary level packaging of one or two dimensional barcode.
3. At tertiary level packaging of one dimensional barcode.

12. AMENDMENTS OF 2016
 GSR 11E, 6 January, 2016
 In rule 122DA,(Application for permission to conduct clinical trials
for New Drug/Investigational New Drug) the following shall be
inserted
‘No permission for the conduct of clinical trials indented for the
academic purpose in respect of approved drug formulation shall be
required for any new dosage form or new route of administration where,
1. the trial should be approved by the ETHICS COMMITTEE.
2. the data generated is not intended for the submission to the
licensing authority.

13.  GSR 790E, 12 August, 2016
 In rule 96(Manner of labeling), the following shall be inserted:
‘‘In addition to the other particulars which are required to be printed or
written under these rules, the label of innermost container of the
following categories of drugs and every other covering in which the
container is packed shall bear a conspicuous red vertical band on
the left side running throughout the body of the label which should not
be less than 5 mm in width, in which words “Scheduled Drug” in
black colour shall be overprinted and without disturbing other
conditions printed on the label under these rules, namely:-
Narcotic analgesics, hypnotics, sedatives, tranquillizers,
corticosteroids, hormones, hypoglycemic, antimicrobials,
antiepileptic, antidepressants, anticoagulants, anti-cancer drugs
and all other drugs falling under Schedules G, H, H1 and
Schedule X whether covered or not in the above list.

14. AMENDMENTS OF 2017
 GSR 78E, dated 31 January, 2017.
 These rules may be called the Medical Devices Rules, 2017 and
will be effective from January 1st, 2018.
 This rule shall be applicable to substances used for in vitro diagnosis
and surgical dressings, surgical bandages, surgical staples, surgical
sutures, ligatures, blood and blood component collection bag with or
without anticoagulant, mechanical contraceptives including condoms,
intrauterine devices, tubal rings etc.
 ..DocumentsMedical Device Rule gsr78E(1).pdf

15.  GSR 101E, 2 February, 2017
 In the rule 122P (Conditions of license for maintaining the blood
bank), the following shall be inserted:
‘The whole human blood and blood components may be transferred,
under prescribed storage conditions, to another blood bank which
have facilities to store and monitor blood distribution. (xv) The
recipient blood bank shall not further transfer units obtained from
another blood bank except to another blood storage centre or a
patient’.

16.  GSR 102E:
 In rule 74, the following shall be inserted:
‘the applicant shall submit the result of bioequivalence study referred
to in Schedule Y, along with the application for grant of a license of
oral dosage form of drugs specified under category II (low solubility
high permeability) and category IV ( low solubility low permeability)of
the biopharmaceutical classification system’.

17.  In rule 36(Import of drugs for personal use), the following shall be
inserted:
‘ 36A Import of drugs by charitable hospital free of cost.—(1) Small
quantity of drugs received in donation by a charitable hospital for the
purpose of treatment of the patients in the said hospital may be
imported provided the drugs are given or administered to the patients
free of cost.’
‘ The drugs shall not be prohibited for import and permitted to be
marketed in the country with residual shelf life of one year or more.’

18.  In rule 63, the following shall be inserted:
‘Duration of license- A license issued in Form 20, 20A, 20B, 20BB, 20F,
20G, 21, 21A, 21B and 21BB shall remain valid, if licencee deposits a
license retention fee referred to in sub-rule (2) before the expiry of a
period of every succeeding five years from the date of its issue, unless, it
is suspended or cancelled by the licensing authority’.
The license retention fee referred to in sub-rule (1) shall be equivalent to
the respective fee required for the grant of such license.
If the licensee fails to pay license retention fee on or before the due date
as referred to in sub-rule (1), he shall be liable to pay license retention
fee along with a late fee calculated at the rate of two per cent. of the
license fee.
in the event of non-payment of such fee, the license shall be deemed to
have been cancelled.”.

19.  After rule 65A(Additional information to be furnished by an applicant
for license or a licensee to the Licensing Authority), the following rule
shall be newly inserted:
‘65B- Inspection for verification of compliance’
‘The licensing authority shall cause inspection, by the Inspector
appointed under the Act, of each premises licensed under this Part, to
verify the compliance with the conditions of license and the provisions of
the Act and these rules at least once in a year.”
 In rule 122P( Conditions of license), the following shall be inserted:
‘ The whole human blood and blood components may be transferred,
under prescribed storage conditions, to another blood bank which have
facilities to store and monitor blood distribution. The recipient blood banks
shall not further transfer units obtained from another blood bank except to
another blood storage centre or a patient ’

20.  In rule 97 (Labeling of medicines),
if it contains a drug substance specified in Schedule G, be labeled with
following words in legible black colored font size in completely red
rectangular box:
SCHEDULE G- PRESCPRIPTION DRUGS-CAUTION
It is dangerous to take this preparation except under
medical supervision.

21.  If it contains a drug substance specified in Schedule H, be labeled
with symbol Rx and conspicuously displayed on the left top corner of
the label and shall also be labeled with the following:
SCHEDULE H- PRESCRIPTION DRUGS-CAUTION
Not to be sold by retailer without the prescription of a
registered medical practitioner.

22.  if it contains a drug substance specified in Schedule H and comes within
the purview of the Narcotic Drugs and Psychotropic Substances Act,
1985 (61 of 1985) be labeled with symbol NRx which shall be in red and
conspicuously displayed on the left top corner of the label and shall also
be labeled with the same as above.
 if it contains a drug substance specified in Schedule X, be labeled with
symbol XRx which shall be in red and conspicuously displayed on the
left top corner of the label.
 In rule 67C( For selling and exhibiting of homeopathic drugs), the
following shall be inserted:
“Provided that no license shall be required for exhibiting the drugs for
promotional activities in any fair.”

23. AMENDMENTS OF 2018
 GSR 222E, dated 13 March, 2018
 In rule 96:
 [the proper name of the drug shall be printed or written in a more
conspicuous manner than the trade name, if any, which shall be
shown immediately after or under the proper name and shall be]
 was substituted with
 “For this purpose, the proper name of the drug or fixed dose
combination drug other than fixed dose combinations of vitamin and
other fixed dose combinations containing three or more drugs, shall
be printed or written in a conspicuous manner which shall be in the
same font but at least two font size larger than the brand name or the
trade name, if any, and in other cases the brand name or the trade
name, if any, shall be written in brackets below or after the proper
name and shall be”.

24.  GSR 1352E, dated 23 March, 2018
 ‘The Central Government prohibits the manufacture for sale, sale
and distribution of the test kits used in ‘Antibody Detecting Rapid
Diagnostic Tests for routine diagnosis of malaria’ with immediate
effect’.
 It was found that the use of these tests for routine diagnosis of
malaria as serological testing was not practical for routine diagnosis
of acute malaria as it produced false positive results.
 People with fever who tested positive in the rapid antibody test,
were later tested negative in antigen test.

25. THANKYOU