The document discusses Good Regulatory Practices (GRP) relevant to community pharmacies, hospital pharmacies, pharmaceutical manufacturing, and the import and export of drugs and medical devices, outlining essential documentation, licensing processes, and e-governance systems. It emphasizes the importance of maintaining detailed records, compliance with various licensing requirements, and adopting online systems to enhance transparency and efficiency in regulatory processes. It also highlights that licenses remain valid upon payment of a retention fee, and a set of guidelines is available to aid in understanding regulatory procedures.

1. GOOD REGULATORY PRACTICE
PRESENTED BY :-
MR. SHUBHAM WANKHEDE
ASSISTANT PROFESSOR
SATYAJIT COLLEGE OF PHARMACY,
MEHKAR

2. CONTENT
DEFINITION
COMMUNITY PHARMACY RETAIL AND
WHOLESALE PHARMACY
HOSPITAL PHARMACY
PHARMA MANIFACTURING
IMPORT OF DRUG AND MEDICAL DEVICE
EXPORT OF DRUG AND MEDICAL DEVICE

3. DEFINATION
Good regulatory practice are
internationally recognized process,
system, tools and method for
improving the quality of regulation.

4. COMMUNITY PHARMACY (RETAIL
SALE) WHOLESALE BUSINESS
The pharmaceutical wholesaler act as intermediary
between pharmaceutical industry and customer by
purchasing and distrubuting medicine to theire
customer.
Good regulatory practise in community pharmacy
and wholesale business including, documentation,
licences, reneval and e governance.

5. Documentation :
All the medical stores /pharmacies (Retailer and
Wholesaler have to maintain various record as per drug
and cosmatic Act 1940 and rules framed thereunder.
1) Correspondence with licensing Authority :
Lincence retention fee record, record of change in
Constitution or change in premises, if any and record of
suspension of lincence,if any.
2) Licenses :
Copies of all documents submitted while grant of license.
Copies of the retail sale and wholesale drug linceses.
3) Inspection record :
Copies of all inspection done by licensing authority.

6. 4) Register Pharmacist (RP) :
Certificate of qualifications, pharmacist pharmacist
registration certificate and address proof . In case of
change register pharmacist, the copies of all dacument
regarding change of register pharmacist I. e. Application to
FDA
5) purchase record of drug :
All the purchase invoice, payment record including
purchase bill with cash or credit memo and transportation
record of drug.
6) Sale record of drug :
Maintain sale record of drug through invoice book having
all the details as per act. sale of schedule drug must be
under the personal supervision of Register pharmacist .

8. 7) Prescription Register :-
The record of the drug to be sold on the prescription of
the register medical practitioner. The following particular
shall be entered in the register.
a) Serial number of entry.
b) the date of supply.
c) the name and adress of prescriber.
d) the name and adress of patients.
e) the name of drug or preparation and quantity.
f) in case of drug specified in schedule C , H or
Schedule H1, the name of manifacture of the drug,
it's batch number and date of expiry.
g) the signature of register pharmacist.

9. 8) Schedule H1 register :
Separate register for schedule H1 drug should be
maintained.
9) NDPS Record : All the sale record of the NDPS drug, as
per direction of licensing authority.
10) Record of expiry drug :
Record of expiry drug I. e. correspondence with dealer
for returing the expired drug.
11) Record of NSQ drug (Not of Standard Quality) :
Record of NSQ drug sampled from the medical store and
declared by Govt. Analyst if any.

10. Licenses
Retail sale :
i. For drug other than specified in schedule C, C(1) and X
:Form 20.
ii. For drug those specified in schedule C and C (1) Form
-21.
iii. For schedule x drug -Form 20 F.
Wholesale
i. For drug other than specified in schedule C, C(1) and
X :Form 20.B
ii. For drug those specified in schedule C and C (1) Form
-21.B
iii. For schedule x drug -Form 20 G.

11. Renewals :
Now there is such no renewal system. A licence
shall the remain valid if licence deposit a prescribe
licence retention fee before the expiry of period of
every succeeding in 5 years from the date of its
issue,
If the licence fails to pay licence retention fee on
or before the due date he shall be liable to pay
licence retention fee along with a late fee and in
the event of non payment of such fee the licence
shall be deemed to have been cancelled.

12. E-governance:
Licensing authority of state has presented the guideline
manual for the easy understanding of processing of
various application through online system .
It is made completely paperless.
This effect is to bring transparency and uniformity in
processing of various application.
The manual is available in regional language and
English.
The web portal http://xlnindia.gov.in is provided. All
details are given under XLN-Xtended Licensing,
Laboratory and Legal Node.

13.  All required dacument are to be scanned. After getting
user id and password , these dacument are uploaded.
Application submission of dacument, verification,
payment of fee through GRAS system, grant and
renewal of retail, wholesale manufacturing, import
licenses ets are processed through online only.
Dacument can be maintained electronically to have
easy traceability.

14. HOSPITAL PHARMACY
It is a health care service department of hospital which
receive drug and supplies, store ,dispence them and
medical device to inpatients and outpatient under
supervision of legally qualified register pharmacist.
It also play the role of advising patients ,doctors nurses
and other healthcare professional on there safe,
effective and efficient use.
Good regulatory practice in hospital pharmacy
including documentation licence renewal and e
governance are explain below.

15. Dacumentation :
1. Statury dacument such as regulatory license, registration,
permission etc.
2. Operational dacument such as purchase invoice, sales invoice.
3. Other necessary dacument such as
I. Protocols
II. Standard Working Procedure
III. Operation instructions
IV. Quality manual
V. Cleaning and maintenance record
VI. Complaint record
VII. Audit record
VIII. Policy dacument
IX. Personal Dacument 1)Patient helth profile 2) Patients medication
record

16. 4. Record of prescription : Prescription must contain -
patients name age sex adress and institution /hospital along
with its strength (especially in paediatric age group), it's
dose frequency, duration in days, and total quantity (number
of tablet and capsule)
5 Laboratory investigation report
6 Refferal notes : Always keep carbon copy of refferal note
especially in case of critically ill patient. Referal note should
mention the date and time of writing note. Also write
treatment given.
7 Discharge Card : It shows conditions of patients on the
admission, investigation done, the treatment given and
detail advice on discharge should be written discharge card.
8 Copies of medical certificate issued as written evidence
and accepted in court of low if required.

18. Renewal
Now there is such no renewal system. A licence
shall the remain valid if licence deposit a prescribe
licence retention fee before the expiry of period of
every succeeding in 5 years from the date of its
issue,
If the licence fails to pay licence retention fee on
or before the due date he shall be liable to pay
licence retention fee along with a late fee and in
the event of non payment of such fee the licence
shall be deemed to have been cancelled.

19. E-governance
EMR (Electonic Medical Record) system can be used to bring
all the patient related data to single platform. Along with
patients medical history, prescription can be maintained
electronically at a single platform.
 Licensing authority of state has presented the guideline
manual for the easy understanding of processing of various
application through online system .
It is made completely paperless.
This effect is to bring transparency and uniformity in
processing of various application.
The manual is available in regional language and English.
The web portal http://xlnindia.gov.in is provided. All details
are given under XLN-Xtended Licensing, Laboratory and Legal
Node.

20.  All required dacument are to be scanned. After
getting user id and password , these dacument are
uploaded.
Application submission of dacument, verification,
payment of fee through GRAS system, grant and
renewal of retail, wholesale manufacturing, import
licenses ets are processed through online only.
Dacument can be maintained electronically to have
easy traceability.

21. PHARMA MANUFACTURING
Pharma manufacturing reffer to the industrial scale
synthesis of Pharmaceutical drug as the part of
pharmaceutical industry .
It covers manufacturing of bulk drug,extract of
plant ,formulation (allopathic drug ,ayurvedic drug,
homeopathic drug ) etc.
Good regulatory practice in pharma manufacturing
including documentation licence renewal and e
governance are explain below.

22. Dacumentation
Record should be maintained as per schedule U and U(I) of Drug and
Cosmatic Act. This include
I. Manufacturing license
II. Products master record
III. Batch Manufacturing Record
IV. Material/component record
V. Personal record(Adequate Staff)
VI. Adequate testing facility
VII. Equipment log book
VIII. Cleaning log book
IX. Record of Distribution of each batch of product
X. Record for return , product recall and customer complaint
XI. Validation record including protocols, plan, design qualifications,
installation qualifications, operational qualifications and
performance qualifications.

23. Licenses
1 Manifacture for sale of drug other than those specified in
schedule C, C1 and X:Form 25
2Manifacture for sale of drug specified in schedule x and not
specified in schedule C and C1 Form 25 F
3 Manifacture drug specified schedule C, C1 Form 28 and Form
28 B for including schedule x
Renewal
Manufacturing licenses shall remain valid, if licenses deposit a
prescribed licenses retention fee before expiry of a period of
every succeeding five years from the date of it's issue.
It the licenses fail to pay license retention fee on or before due
date, he shall be liable to pay license retention fee along with
late fee, and event of non payment of such fee, the license shall
be deemed to have been cancelled.

24. E-governance
 Dacument can be maintained electronically to have easy
traceability.
 Licensing authority of state has presented the guideline
manual for the easy understanding of processing of
various application through online system .
It is made completely paperless.
This effect is to bring transparency and uniformity in
processing of various application.
The manual is available in regional language and English.
The web portal http://xlnindia.gov.in is provided. All
details are given under XLN-Xtended Licensing,
Laboratory and Legal Node.

25.  All required dacument are to be scanned. After getting user
id and password , these dacument are uploaded.
Application submission of dacument, verification, payment of
fee through GRAS system, grant and renewal of retail,
wholesale manufacturing, import licenses ets are processed
through online only.
 SUGAM is e-Governance system to discharge various
function performed by CDSCO under Drug and Cosmatic Act,
1940.
It is an online web portal where applicant can apply for NOCs,
licenses, registration certificate, permission and approval.
It also enables CDSCO official to process the application
online and generate the permission online and generate MIS
report.

26. IMPORT OF DRUG AND MEDICAL
DEVICE
 Good regulatory practice in import of drug including
dacumentation, licenses, renewal and e-governance
are explained below.
Dacumentation
1) Authorizing letter issued by Director/Company
Secretary/Partner of indian agent firm revealing the
name and designation of the person authorized to sign
form 40 and power of Attorney.
2) Power of Attorney: The authorization by a
manifacture to his agent in India.

27. 3) Wholesale license issue to manifacture or it's agent by the
state licensing authority in India.
4) Undertaking signed and stamped by manifacture
/Authorized agent.
5) Schedule D (2) requirement
Standard of Drug : Imported drug complied as IP, USP, BP, EP.
Label Submission: True copy of label as perper respective
official book.
Testing of drug : Method of analysis, COA tested in theire
laboratory, impurity standard , marker compound, reference
standard along with its COA where ever applicable.
6) Free Sale Certificate (FSC) : FSC should state that that the
proposed drug is freely sold in Contry of Origin.

28. 7)Certificate of Pharmaceutical Products (COPP) : The
valid copy of GMP certificate or COPP as per WHO scheme
for each drug issued by the National Drug Regulatory
Authority of the country of origin.
8) Manufacturing Lincence : The valid copy of the
Manufacturing lincence or Market Authorization certificate
issued by National Drug Regulatory Authority of contry of
origin.
9) Product registration Certificate: The valid copy of
registration certificate wherever applicable in respect of
foregen manufacturing site.
10) Recall register
11) Record of sales of drug for the import of which a
lincence is required, showing particular of drug and of
person to whom it is sold and such other particular.

29. 12) Separate register for sale or distribution of schedule X
drug, showing the particular
a) Name of Drug
b) Batch Number
c) Name and adress of manifacture
d) Date of transaction
e) opening stock on the business day
f) Quantity of drug received, if any, and source from which
received
g) Name of purchaser, his adress and licenses number
h) Balance quantity of drug at the end of business day
i) Signature of the person under whose supervision the
drug have been supplied.

30. Licenses
In Form 10 for the import of drug other than schedule X
and
In Form 10A for the import of drug specified in schedule
X
The CDSCO issue licenses to medicine that are imported
india.
E-Governance
Filing application, submission of dacument, verification,
payment of fee through GRAS system, grant and renewal
of, manifacturing, import lincence ets are processed
through online only.

31. SUGAM is e-governance system to discharge various
function performer by CDSCO under drug and cosmatic
act 1940.
It is online web portal where applicant can apply for
NOCs, licenses, registration certificate, permission and
approval.
It also enable CDSCO official to process the application
online and generate the permission online and generate
MIS(Management Information System) report.

32. EXPORT OF DRUG AND MEDICAL
DEVICE
Export means to send (good or service) to another
contry for sale.
Export are product and service that are produced
domestically, but then sold to customers residing in
other countries.
Good regulatory practice export ofof drug including
dacumentation, licenses, renewal, and e-
governance.

33. Dacumentation :
1. Copy of company Incorporation Certificate
2. Copy of Valid Export order and NOC issued on a case to
case basis against each such order.
3. NOC for manifacture of new (Unapproved) drug solely
export from DCGI.
4. Details of premices where the drug is to be manifactured
for export.
5. Record of quality control of the batch to be exported
6. Record showing that no part of drug to be exported is
divided for domestic sale in India.
7. Information regarding each consignment dispatched,
remaining stock of drug and related row material and
intermediate in hand.

34. 8. Record to ensure physical destruction of all unexported quality of drug.
9. Each consignment of export shall be accompanied with requisite import
license from importing contry.
10. WHO GMP certification
11. Dossier contains following Detail,
a) Product Detail
b) Approved Generic names
c) Strenght per dosage
d) Dosage form
e) Visual description
f) Details regarding the packing
g) List of contries in which product has been approved, regected and
withdrown
h) List of active pharmaceutical ingredients with their property
i) Site of manifacturing and method of synthesis
j) Stability testing
k) Efficacy and safety

35. Licenses and Renewal :
The state licensing authority shall issue the
manifacturing licenses for these formulation on each
export order on basis of a No Objection Certificate from
Drug Controller ,India.
There is no drug licenses required in India when the drug
is being exported from India.
However, the licenses is needed from contry to which
the drug is to be exported.
Secondly, the import export code by the Directorate
General of Foregn Trade(DGFT) is required to exporters
and importers of india.

36. E-governance
Licensing authority of state has presented the guidelines
Manual for the easy understanding of processing of
various applications through online system. It is made
completely paperless.
Dacument can be maintained electronically to have easy
traceability. Information Education and Communication
(IEC) can be obtained by applying on line on Director
General of Foregen Trade portal.(DGFT).

37. 🌹🌹Thank You
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