**Summary:**
In response to concerns regarding the online sale of addictive painkillers and psychotropic drugs, the Ministry of Chemicals and Fertilizers addressed Lok Sabha Unstarred Question No. 3252 on August 8, 2025. The response clarifies that the sale and distribution of all drugs, including painkillers and psychotropic substances, are regulated by State Licensing Authorities (SLAs) under the Drugs and Cosmetics Act, 1940, and its associated rules. SLAs are responsible for implementation, monitoring, and enforcement of these regulations, and can take action against non-compliance.
Furthermore, the Government of India has taken steps to comprehensively regulate online pharmacies. Draft rules were published on August 28, 2018, inviting public and stakeholder feedback on amendments to the Drugs Rules, 1945. These proposed amendments aim to incorporate specific provisions for regulating the sale and distribution of drugs through e-pharmacies. The draft rules address key aspects such as e-pharmacy registration, periodic inspections, distribution procedures, advertising restrictions, complaint redressal, and ongoing monitoring of e-pharmacy operations.
Key Entities Referenced
MINISTRY OF CHEMICALS AND FERTILIZERS: A ministry of the Government of India responsible for chemicals and fertilizers.
DEPARTMENT OF PHARMACEUTICALS: A department under the MINISTRY OF CHEMICALS AND FERTILIZERS, Government of India.
Dr. M K Vishnu Prasad: Member of LOK SABHA who raised the question about sale of addictive painkillers and psychotropic drugs by online pharmacies.
SMT. ANUPRIYA PATEL: The MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS who provided the answer to the question.
State Licencing Authorities SLAs: Authorities appointed by State Government under the Drugs and Cosmetics Act, 1940 responsible for regulating sale and distribution of drugs.
Drugs and Cosmetics Act, 1940: An act regulating drugs and cosmetics in India.
Drugs Rules, 1945: Rules to regulate sale and distribution of drugs through e pharmacy.
Government of India: The governing body of the Republic of India which published draft rules to regulate online sale of medicines.
GOVERNMENT OF INDIA
MINISTRY OF CHEMICALS AND FERTILIZERS
DEPARTMENT OF PHARMACEUTICALS
LOK SABHA
UNSTARRED QUESTION No. 3252
TO BE ANSWERED ON THE 08TH AUGUST 2025
Sale of Addictive Pain killers/Psychotropic Drugs by Online Pharmacies
3252. Dr. M K Vishnu Prasad:
Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:
(a) whether any steps have been taken to monitor sale of addictive Painkillers and Psychotropic
drugs by online pharmacies;
(b) if so, the details thereof along with the action taken thereon; and
(c) whether any data on the end user details is maintained by online pharmacies regarding sale of
such addictive Painkillers and Psychotropic drugs, if so, the details thereof?
ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND
FERTILIZERS
(SMT. ANUPRIYA PATEL)
(a) to (c): Sale and distribution of drugs including painkillers and psychotropic drugs are
regulated by the State Licencing Authorities (SLAs) appointed by State Government under the
Drugs and Cosmetics Act, 1940 and the rules made thereunder. SLAs are empowered under the
said Act and rules for implementation of its provisions and monitoring and in case of non-
compliance, they may take action in accordance with the provisions of the said Act and rules.
Further, with a view to comprehensively regulate online sale of medicines, the
Government of India has published draft rules vide its notification dated 28.8.2018, inviting
comments from public and stakeholders on amendments to the Drugs Rules, 1945 for
incorporating provisions relating to regulation of sale and distribution of drugs through e-
pharmacy.
The draft rules contain provisions for registration of e-pharmacy, periodic inspection of
e-pharmacy, procedure for distribution or sale of drugs through e-pharmacy, prohibition of
advertisement of drugs through e-pharmacy, complaint redressal mechanism, monitoring of e-
pharmacy, etc.
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