DCC deliberates on defining and regulating OTC drugs

Excerpts from the Minutes of the 55th Meeting of the Drugs Consultative Committee held on 31.01.2019 and 01.02.2019 at New Delhi

“Agenda No. 8: Consideration of the report submitted by Sub-Committee of Drugs Consultative Committee (DCC) on over-the-counter (OTC) drugs

DCC was apprised that a sub-committee was constituted in 52nd meeting held on 18.09.2017 under the chairmanship of Dr. Ravi Shankar IPS, Director General, DCA, Andhra Pradesh to examine comprehensively the drugs marketed in country vis-à-vis conditions for sale stipulated under various schedules, namely H, H1, G, X, K and recommend the list of drugs which may be considered for marketing as OTC along with conditions to be followed.

The sub-committee examined the matter in detail and submitted its report. The sub-committee has given recommendations on the following aspects on OTC drugs.

1.     Definition of OTC drug

2.     Basic Characteristics of OTC drugs

3.     Classification of OTC drugs

4.     Preparation of Initial list of OTC Drugs

5.     Regulation of Rx Drug to OTC Drug Switch Process

6.     Regulation of new OTC drug approval

7.     Manufacturing and labelling of OTC drugs

8.     Distribution and sale of OTC drugs

9.     Advertisement of OTC drugs

10.  Pricing

11.  Miscellaneous

DCC opined that detailed examination of the report submitted by subcommittee is required to take further action in this regard. Therefore, DCC constituted a subcommittee under chairmanship of Shri. N.K. Ahooja, Drugs Controller, Haryana to examine the report on Over-The-Counter (OTC) drugs.

Composition of sub-committee:

1.     Shri. N.K. Ahooja, (Chairman), Drugs Controller, Haryana

2.     Shri. Amaresh Tumbagi, (Member), Drugs Controller, Karnataka

3.     Shri. R. Chandrashekhar, (Convener) , DDC (I), CDSCO (HQ)

The sub-committee shall examine the report and submit their recommendations to DCC for further consideration.”

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA