**Policy Summary: Implementation of Drugs and Cosmetics Fourth Amendment Rules, 2013 – Schedule H1 Clarification**
This document, dated March 19, 2014, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization, addresses the implementation of the Drugs and Cosmetics Fourth Amendment Rules, 2013, specifically concerning the inclusion of Schedule H1 under the Drugs and Cosmetics Rules, 1945. The amendment, published under Gazette notification G.S.R. 588E on August 30, 2013, incorporates certain antibiotics, anti-TB drugs, and habit-forming drugs into Schedule H1.
The notification stipulated that the rules would be effective from March 1, 2014. However, representations from Drug Manufacturers Associations and individual manufacturers raised concerns regarding the sale of drugs covered under Schedule H1 that were manufactured before this date and not labelled according to the amended rules.
The Ministry of Health and Family Welfare has decided that drugs included in Schedule H1 manufactured up to February 28, 2014, and labelled as per the regulations applicable at the time of their manufacture, may continue to be sold beyond March 1, 2014.
It is imperative that chemists selling drugs included in Schedule H1 adhere to the requirements outlined in the notification regarding the sale of these drugs only against the prescription of a Registered Medical Practitioner (RMP) and the maintenance of accurate sales records.
The Drugs Controller General, Dr. G.N. Singh, is the issuing authority.
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 Organization: National Regulatory Authority (NRA) of India.
Drugs and Cosmetics Fourth Amendment Rules, 2013: Amendment to the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics Rules, 1945: The principal rules governing drugs and cosmetics in India.
Schedule H1: A schedule under the Drugs and Cosmetics Rules, 1945 containing certain antibiotics, anti-TB drugs and habit forming drugs.
All India Chemist and Druggist Association: Association representing chemists and druggists in India.
Ministry of Health and Family Welfare: A ministry of the Government of India.
Dr. G.N. Singh: Drugs Controller General of India.
File No. 18-9/2010-DC
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road
New Delhi-110002
To,
DN All State/UT’s Drugs Controllers
Zonal and sub-zonal offices
Manufacturers Associations Dated:-19.03.2014
Ail India Chemist and Druggist Association
Subject:- Implementation of the Drugs and Cosmetics (Fourth Amendment)
Rules, 2013 published under Gazette notification G.S.R. 588(E) dated
30.08.2013 regarding the inclusion of Schedule H1 under the Drugs
and Cosmetics Rules, 1945 — clarifications thereon.
Sir,
The Drugs and Cosmetics Rules, 1945 were amended vide Drugs and
Cosmetics (Fourth Amendment) Rules, 2013 published under Gazette notification
G.S.R. 588(E) dated 30.08.2013 regarding the inciusion of Schedule H1 under the
Drugs and Cosmetics Rules, 1945 containing certain antibiotics, anti-TB drugs and
habit forming drugs. It was provided in the notification that these rules will come into
force after six months of their publication in the official Gazette i.e. from 1° March,
2014.
Representations were received from the Drug Manufacturers Associations as
well as Individual manufacturers that the chemists may not be able to sell the drugs
covered under the Schedule H1 which are not labelled as per provisions of the
amended rules even though these drugs at the time of their manufacture were labelled
in accordance to the rules applicable to them.
The representations have been considered by the Ministry of Health and Family
Welfare, Government of India and it has been decided that the drugs included in the
Schedule H1 manufactured upto 28" February, 2014 without the labelling
requirements specified in the said notification but labelled as per provisions applicable
for them at the time of their manufacture, may continue to be sold even beyond 1*
March, 2014. The Chemist, while seiling the drugs included in Schedule H1, would,
however, be required to comply with the requirements for the sale of drugs covered
under the said notification in respect of requirements of sale of these drugs against the
prescription of an RMP and maintenance of sale records as specified therein.
Yours,faithfully,
(Dr. G./N. Singh)
Drugs Controller General (I)
Copy forwarded for information to:
1. Addl. Secretary & DG (CGHS), Ministry of Health and Family Welfare.
2. Joint Secretary (Regulation), Ministry of Health and Family Welfare.