Lok Sabha Question No. 11 (STARRED), answered on 2017-12-15
Subject: Over-the-Counter Sale of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: BAIJAYANT "JAY" PANDA

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO. 11 TO BE ANSWERED ON THE 15 TH DECEMBER, 2017 OVER - THE - COUNTER SALE OF DRUG S

## *11. SHRI BAIJAYANT JAY PANDA:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the Government has taken any steps to prevent over - the - counter sale of drugs included in Schedules H and H1 of the Drugs and Cosmetics Act, 1940;
- (b) if so, the details the reof;
- (c)  whether  the  Central  Drugs  Standard  Control  Organisation  (CDSCO)  has  t responsibility  of  ensuring  that  Schedule  H  and  Schedule  H1  drugs  are  not over - the - counter;
- (d) if so, the details thereof including the steps taken by CDSCO in this regard; and
- (e)  whether  all  drugs  used  for  treating  drug  resistant  tuberculosis  hav included in Schedule H1, if so, the details thereof and if not, the reasons t

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE ( SHRI JAGAT PRAKASH NADDA )

- (a)to ( e) : A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 11* FOR 15 TH DECEMBER, 2017

(a) & (b): -Sale and distribution of drugs in the country is regulated as p provisions under the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetic Rules,  1945  made  thereunder.  As  per  the  said  Rules,  drugs  specified Schedule H, H1 or Schedule X cannot be s old except on and in accordance with the prescription of a Registered Medical Practitioner (RMP) .

(c) & (d): - The manufacture, sale and distribution of drugs in the country regulated  under  the  provisions  of  Drugs  &  Cosmetics  Act,  1940  and  Rule 1945 thereunder  through  a  system  of  licensing  and  inspection.  Licenses manufacture, sale and distribution of drugs are granted by the State Lic Authorities (SLAs) appointed by respective State Governments. Licensees required  to  comply  with  all  the conditions  of  license.  SLAs  are  legally empowered to take stringent action against violation of any provision of t and Rules.

While  State  authorities  are  primarily  responsible  for  regulatio manufacture,  sale  and  distribution  of  drugs, Central  Drugs  Standard  Control Organisation  (CDSCO)  is  mainly  responsible  for  approval  of  New  Drugs, Clinical Trials, laying down the standards for drugs, control over the qu imported drugs, coordination of the activities of State Drug Con Organizations, etc.

CDSCO from time to time sensitizes State Licensing Authorities to ens compliance  of  various  provisions  of  the  Drugs  &  Cosmetics  Act  and  Rule including measures to ensure that Schedule H and H1 drugs are not sold without prescription of R.M.P.

(e) : All the drugs for treating drug resistant tuberculosis have been incl Schedule  H1  except  Kanamycin,  Streptomycin  and  Ofloxacin,  which  are already included in Scheduled H to the Drugs & Cosmetics Rules, 1945. Elev anti  tuberculosis  drugs  have  been  introduced  in  the  Schedule  H1  w. 1.03.2014 through  amendment  in  Drugs  &  Cosmetics  Rules,  1945  following due procedures and consultation with Revised National Tuberculosis Cont Program (RNTCP) of India.