Manufacture of Drugs

Manufacture in relation to any drug includes any process or part of a process for making,
altering, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with
a view to its sale and distribution, but does not include compounding or dispensing of any drug or
packing of any drug in ordinary course of retail business.
Manufacture of drugs is a blend of art and science, to be achieved strictly in accordance with the
provisions of Good Manufacturing Practices (GMP).
Prohibition of manufacture and sale of certain drugs
The following categories of drugs and cosmetics are prohibited to be manufactured or sold in
our country.
1. Any drug or cosmetic which is substandard, misbranded, adulterated or spurious.
2. Any patent or proprietary medicine without clear indication of ingredients.
3. Any drug claiming for accurate cure or prevention of diseases listed in Schedule J.
4. Any manufacturing of formulation containing drug or cosmetic which has been imported into our
country in contravention to the provisions of the Act and Rules.
5. Manufacturing for sale of any drug or cosmetic containing any harmful ingredient.
6. Manufacturing for sale of any drug or cosmetic in contravention to the provisions of the Act and
Rules, provided that manufacture of small quantities of any drug for the purpose of examination,
test or analysis is permitted, subject to prescribed conditions.
Conditions for grant of license and conditions of license for manufacture of drugs
A person who is interested in starting manufacturing of drugs is required to fulfil several
conditions laid down in DCA and Rules. The conditions to be fulfilled before licence is granted
are collectively called as “Conditions Precedent” and conditions that are required to be fulfilled
after the licence is obtained for manufacturing are called “Conditions Subsequent”. The Licensing
Authority is both in States and at Central Government. The Central Government is empowered to
prohibit manufacturing and sale of any drug formulation in public interest. The types of licenses
are granted are,
1. Licence for manufacturing of drugs for examination, test or analysis
2. Licence for manufacture of new drug
3. Manufacturing under Loan licences
4. Licence for Repacking
5. Licence to Manufacture of drugs other than Schedule C, C(1), and Schedule X
6. Licence to Manufacture of drugs in Schedules C, C (1) and Schedule X
 Manufacture of drugs
Licences are required for the manufacturing of following categories of drugs.
1. Manufacturing of drugs for examination, test or analysis
2. Manufacture of new drug
3. Loan licences
4. Licence for Repacking
5. Licence to Manufacture of drugs other than Schedule C, C(1), and Schedule X
6. Licence to Manufacture of drugs in Schedules, C (1) and Schedule X
1. Manufacturing of drugs for examination, test or analysis
A licence is necessary to manufacture any drug in small quantity for the purpose of
examination, test or analysis.
If the manufacturer does not hold separate licence for test, analysis or examination, the licence
is obtained in Form 29. The provisions relating prohibition of manufacturing of certain drugs do
not apply for manufacturing meant for test or analysis. In case of a drug not recognized as safe for
use, a licence in form 29 can be granted only on producing a no objection certificate from the
licensing authority appointed by the central government. The validity of the licence is for I year.
Drugs should be kept in containers bearing labels indicating the purpose for which it has been
manufactured
Conditions for grant of licence
1. The manufactured drugs should be kept in containers bearing appropriate label indicating the
purpose of test or analysis.
2. The drugs should be used for the purpose for which they are manufactured.
3. When the material is supplied to other manufacturer, the label stating the name and address of
manufacturer, scientific name of the drug, licence number, date of manufacture etc., should be
provided.
4. The manufacturer should allow the Inspector to inspect the premises, manufacturing, and
analytical records and withdraw the samples if required for analysis. The manufacturer should
comply with the provisions of the Act and Rules.
5. The manufacturer should maintain an Inspection Book and the same be shown to the Inspector.
6. The licensee should comply with other requirements for which a notice has been given to him one
month before by the Licensing Authority
.
2. Manufacture of new drug
A new drug is defined as a drug the composition of which is such that it is not generally
recognised among experts as say for use under the conditions recommended on the label.
Following provisions are applicable to the manufacture of a new drug whether classifiable
under schedules C and C1,
a) No new drug can be manufactured unless prior approval of the licensing authority is taken.
b) Applicant issued produce all a documentary and other evidence relating to the standards of quality
purity strength and other information’s as may be required including the results of a therapeutic
trials carried out on the new drug
c) While applying for a licence to manufacture a new drug or its preparation, an applicant should
produce along with his application evidence that the drug has already made approved
In addition to provisions for manufacture of drugs, there should be documentary evidence
for quality, purity, therapeutic trials of new drugs and evidence for approval under schedule ‘Y’
(Clinical trials).
3. Manufacturing under Loan licences
Loan license is given to a person who does not have his own arrangements for
manufacturing but wishes to avail the manufacturing facilities owned by another licensee. For
drugs other than Schedules C, C (I) and X, loan licences can be given.
A licence is obtained from licensing authority on application in prescribed form No. 24
A, with prescribed fees and issued by Licensing Authority in Form 25-A, which is valid for 1 year.
Before the Grand of long licence the licencing authority shall get the premises inspected by one or
more inspectors. The Inspector shall examine all portions of the premises, plant, process of
manufacture, means for standard icing and testing the drugs. For manufacturing of additional items
on a long licence and application should be made to the licensing authority. Licensee should
maintain the relevant records of the raw materials and finished products for a period of 5 years
from the date of manufacture (2 years in case of drugs having expiry date from the date of expiry).
Loan licence is deemed to be cancelled or suspended if the licence owned by the long licensee,
whose manufacturing facilities have been availed by the licensee is suspended or cancelled.
4. Licence for Repacking
Repacking licence are granted for the purpose of breaking up any drug other than those
specified in scheduled c and C1 on application to the licensing authority in form 24 B and the
licence issued in form 25 B
Conditions
a. Adequate space and equipment should be provided. Hygienic conditions of working should always
be maintained.
b. Repacking should be supervised by competent person.
c. There should be adequate arrangement for testing of samples.
d. The licence should always be displaced at premises of repacking.
e. The factory premises for repacking should comply with provisions of Schedule M.
Adequate staff should be appointed and any change in staff structure should be immediately
informed to Controlling Authority.
f. The container or package of repacked drug should bear on its label the words – “Rpg.Lic.No”.
g. The licence is valid till 31Ist December every year and required to be renewed. There should be
separate application for separate licence.
5. Manufacture of drugs other than Schedule C, C(1), and Schedule X
A license is obtained from licensing authority on application in prescribed Form No, 24 for the
manufacture of C, C1 and 24 for 24 F for schedule X, with prescribed fees. If conditions are
fulfilled then license is issued in prescribed Form No. 25 and 25 F respectively.
Conditions for grant of licence
The factory premises shall comply with conditions laid down in the Schedule M.
1. The manufacture shall be conducted under active supervision of Competent Technical Staff
consisting at least one who is,
- A graduate in pharmacy or pharmaceutical chemistry from me recognized university and had at
least 18 months practical experience after graduation in the manufacture of drugs
- A graduate in science from a recognized university with chemistry as main subject and who had
at least 3 year experience in the manufacturer of drug after graduation
- A graduate in chemical engineering or chemical technology or medicine from a recognized
University with a practical experience of not less than 3 years in the manufacturer of drugs after
graduation
2. Adequate facilities for testing should be provided and it should be separate from manufacturing
unit.
3. Adequate facilities for storage of drugs.
4. Licensee must allow an Inspector to inspect the premises, check the record and to take the sample.
5. Licensee must display the licence on the premises and produce it when asked for.
6. Licensee must pay fees and get endorsement on the licence if the licensee wishes to manufacture
any additional product.
7. Record of testing and manufacture (Schedule U) should be maintained at least for 2 years from the
date of expiry of drugs and for 5 years in case of other drugs.
8. Licensee must provide samples to the Authority.
9. Licensee must furnish the data of stability of drug if demanded.
10. Licensee must provide any additional requirement as directed by Authority.
11. Inspection book must be maintained.
12. The licensee shall comply with the requirements of GMP.

6. Manufacture of drugs specified in Schedules C, C 1 and X

A licence is obtained from licensing authority on application in prescribed Form No. 27 with
prescribed fees, and licence are issued in Form 27B for drugs in schedule C, C1. For schedule
X drugs in Form No. 27B with prescribed fees. If conditions are fulfilled then licence is issued in
prescribed Form No. 28B.
 Conditions for grant of licence
The manufacture shall be conducted under active supervision of Competent Technical Staff
consisting at least one who is,
- A graduate in pharmacy or pharmaceutical chemistry from me recognized university and had at
least 18 months practical experience after graduation in the manufacture of drugs
- A graduate in science from a recognized university with chemistry as main subject and who had
at least 3 year experience in the manufacturer of drug after graduation
- A graduate in chemical engineering or chemical technology or medicine from a recognized
University with a practical experience of not less than 3 years in the manufacturer of drugs after
graduation
2. The factory premises should comply with the conditions prescribed in schedule M and M3 in
respect of medical devices.
3. The applicant should provide adequate space plan and equipment
4. The applicant should provide and maintain adequate staff, premises and laboratory equipment,
the testing unit being separate from the manufacturing unit.
5. The applicant should make adequate arrangements for the storage of drugs manufactured
6. The license shall comply with the requirements of good manufacturing practices laid down in
schedule M
The license in form 28 or 28 B remains valid for a period of 5 years. The application for renewal
of license is made within 6 month of its expiry. If the renewal is not made within 6 months of its
expiry, the license shall be deemed to have expired
Special condition for schedule X
1. Account of all transactions regarding manufacture should be maintained in a serially bound and
paged register as follows. This should be prescribed for 5 years.
2. Manufacturer is required to send the copies of invoice of sale of drugs to licensing authority every
3 months.
3. Preparations should be labelled as XRX (red ink).
4. No Schedule X drugs should be supplied by the way of physician sample.
5. Drugs specified in Schedule X drugs shall be marketed in packaging not exceeding 100 Units dose-
Tablets/Capsule, 300 ml –Oral liquid and 5 ml –Injection.