**Summary:**
This communication, reference number F. No. DCG DMISC2017 93, issued by the Directorate General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Office of the Drugs Controller General of India on August 18, 2017, addresses all State/UT Drugs Controllers. The subject of this communication is a request to advise manufacturers to submit stability data for non-patent and proprietary medicines when applying for manufacturing permission.
The communication references the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945, which mandate safety, efficacy, and quality standards for drugs manufactured and sold in India. While current regulations require stability data for patent or proprietary medicines, this communication requests that State/UT Drugs Controllers advise manufacturers to also submit stability data for non-patent and proprietary medicines. This request aims to ensure the quality, safety, and efficacy of all medicines throughout their shelf life.
The communication is signed by Dr. G. N. Singh, Drugs Controller General of India. Copies have been distributed to JS R, Nirman Bhawan, all Zonal/Sub-Zonal offices of CDSCO, all drug manufacturers associations, and the CDSCO website.
Key Entities Referenced
Directorate General of Health Services: An organization under the Ministry of Health and Family Welfare, Government of India.
Central Drugs Standard Control Organisation: National Regulatory Authority (NRA) of India.
Drugs Controller General of India: Head of Central Drugs Standard Control Organisation responsible for approval of licenses of specified categories of drugs.
State/UT Drugs Controllers: Drug regulatory authorities for respective states and union territories of India.
Drugs Cosmetics Act, 1940: An act to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
Drugs Cosmetics Rules, 1945: Rules made under the Drugs and Cosmetics Act, 1940 to prescribe statuary requirements for grant of license to manufacture for sale and distribution of drugs.
Nirman Bhawan: Office of Ministry of Health and Family Welfare, New Delhi, Delhi
Dr. G. N Singh: The Drugs Controller General of India at the time of the notification.
F. No. DCG (D)/MISC/2017 (93)
Directorate General of Health Services
Central Drugs Standard Control organisation
(O/o Drugs Controller General of India)
18 AUG 2017
To
All the State/UT Drugs Controllers
Subject: Request to advice the manufacturers to submit stability data of non-patent and
proprietary medicines for grant of permission- reg.
Sir,
The Drugs & Cosmetics Act, 1940, is an Act, to regulate import, manufacture,
distribution and sale of drugs and cosmetics. The Drugs & Cosmetics Rules, 1945, made
under the Act prescribe statuary requirements for grant of license to manufacture for sale
and distribution of drugs to ensure safety, efficacy and quality of drugs manufactured and
sold in the country.
One of the conditions for grant of license to manufacture for sale and distribution of
patent or proprietary medicines is that the applicant shall furnish to the licensing authority
evidence and data justifying that the medicines are stable under the condition of storage
recommended.
Stability of drug is of paramount importance to ensure quality, safety and efficacy of
the drugs throughout its shelf life.
In view of above, you are requested to advise the manufacturer under your jurisdiction
to submit the stability data of non-patent and proprietary medicines also at the time of
submission of application for grant of permission to manufacture such medicine to ensure
quality of products.
Yours Faithfully
(Dr. G. N Singh)
Drugs Controller Geveral (India)
cc:
1. JS (R), Nirman Bhawan.
2. All Zonal Sub Zonal of CDSCO
3. All drug manufacturers association\
4. CDSCO website