Lok Sabha Question No. 2985 (UNSTARRED), answered on 2023-03-17
Subject: Quality of Online Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Ghanshyam Singh Lodhi

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

## LOK SABHA UNSTARRED QUESTION NO.†2985 TO BE ANSWERED ON 17 TH  MARCH, 2023

## QUALITY OF ONLINE MEDICINES

## †2985: SHRI GHANSHYAM SINGH LODHI:

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

- (a) whether the Government is aware of the online sale of medicines;
- (b) if so, the companies which are selling medicines online;
- (c)  the  details  of  the  online  companies  selling  medicines  without  license  including  their names and the number of years since when they have been selling their medicines;
- (d) the States in which the network of online selling of medicines exists; and
- (e) the manner in which the Government plans to control the quality of online medicines?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a) to (e): As  informed  by  Central  Drugs  Standard  Control  Organisation  (CDSCO), various representations are received raising concerns regarding sale of drugs through online, internet or other electronic platforms including various mobile applications, in contravention to the provisions of the Drugs and Cosmetics Act, 1940.

Based  on  findings  in  representations  CDSCO  issued  Show  Cause  Notices  on 08.02.2023 & 09.02.2023 to 31 firms engaged in the online sale of the drugs.

The cases concerning quality of drugs when reported, the matter is taken up with the concerned  State  Licensing  Authority  (SLA)  in  order  to  take  necessary  action  under  the provisions  of  Drugs  and  Cosmetics  Act  1940.  The  State  Licensing  Authorities  (SLAs)  are empowered  to  take  action  on  violation  of  any  conditions  of  such  licenses  including prosecution in appropriate Court of law.

CDSCO and Ministry of Health and Family Welfare have taken regulatory measures to ensure the quality of medicines in the country as below:

1. The Drugs and Cosmetics Act, 1940 was amended under Drugs &  Cosmetics (Amendment)  Act  2008  to  provide  stringent  penalties  for  manufacture  of  spurious  and adulterated drugs. Certain offences have also been made cognizable and non-bailable.

2. States/ UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.

3.  The  number  of  sanctioned  posts  in  CDSCO  has  been  significantly  increased  in  last  10 years.

4.  To  ensure  efficacy  of  drugs,  the  Drugs  and  Cosmetics  Rules,  1945  have  been  amended providing  that  applicant  shall  submit  the  result  of  bioequivalence  study  along  with  the application for grant of manufacturing license of oral dosage form of some drugs.

5. The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.

6. The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.

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