**Summary:**
This notice, issued by the Drugs Controller General of India (DCGI) on March 31, 2017, addresses the need to update Schedule H of the Drugs and Cosmetics Rules, 1945. This action follows a request from the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), which highlighted that many topical corticosteroids marketed in India are not currently included in Schedule H (last amended in 2006). The DCGI acknowledges the necessity of updating the list to include drugs approved for marketing post-2006. The notice solicits suggestions from all stakeholders regarding additions or deletions to the list of drugs covered under Schedule H, with a deadline of 30 days for submission. Distribution includes all State/UT Drugs Controllers, the Indian Medical Association, Medical Council of India, Pharmacy Council of India, Nursing Council of India, and Pharma Associations. Copies have also been sent to the Director General of Health Services and the Joint Secretary, Ministry of Health & Family Welfare. The notice was issued from the Office of DCGI, FDA Bhavan, Kotla Road, New Delhi-110002, with reference number No.DCG(I)Misc.2017/36.
Key Entities Referenced
Central Drugs Standards Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, providing technical expertise in public health.
Ministry of Health Family Welfare: A ministry of the Government of India responsible for public health in India.
New Delhi: Capital of India, location of offices mentioned in the notification
Indian Association of Dermatologists, Venereologists Leprologists: A professional association representing dermatologists, venereologists, and leprologists in India.
Schedule H: A schedule of the Drugs and Cosmetics Rules, 1945, listing prescription drugs in India.
Drugs Cosmetics Rules, 1945: Rules governing the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Dr. GJN. Singh: Drugs Controller General of India
No.DCG (I)/Misc./2017 (36)
Central Drugs Standards Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
(Office of DCGI)
FDA Bhavan, Kotla Road,
New Delhi-110002.
Dated: 318*March, 2017
NOTICE
Indian Association of Dermatologists, Venereologists & Leprologists
(IADVL) visited the Office of DCG (|) and raised the issue of updating the
Schedule H of the Drugs & Cosmetics Rules, 1945. It was highlighted that many
of the topical corticosteroids marketed in the country do not figure in the
Schedule H, which was last amended in the year 2006.
It was felt that a need has arisen to update the list of the drugs, as many
drugs which have since been approved for marketing in the country after 2006,
are required to be covered under the Schedule.
All stakeholders are, therefore, requested to give their suggestions for
addition or deletion to the list of drugs to be covered under Schedule H within
30 days.
(Dr. GJN. Singh)
Drugs Controller Gen¢ral (India)
To:
1. All State/UT Drugs Controllers.
2. Indian Medical Association
3 Medical Council of India /Pharmacy Council of India/Nursing Council of
India
4. Pharma Associations
Copy to:
(i) Director General of Health Services, Nirman Bhawan, New Delhi.
(ii) The Joint Secretary ®, Ministry of Health & Family Welfare, Nirman
Bhawan, New Delhi.