1. Misleading advertisements by pharmaceutical and FMCG companies — non-enforcement of Rule 170, Drugs and Cosmetics Rules, 1945 — implementation of consumer and drug laws. (Para 5 , 6 )
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2024 Supreme(SC) 1293
SUPREME COURT OF INDIA
HIMA KOHLI, AHSANUDDIN AMANULLAH, JJ.
Indian Medical Association & Anr. – Appellant
Versus
Union Of India & Ors. - Respondent
Writ Petition (Civil) No. 645 of 2022
Decided on : 23-04-2024
Advocates:
Advocate Appeared:
For the Petitioner: Mr. P.S. Patwalia, Sr. Adv. Mr. Prabhas Bajaj, Adv. Mr. Priyanshu Tyagi, Adv. Mr. Rishav Rai, Adv. Mr. Amarjeet Singh, AOR
For the Respondent: Mr. K M Nataraj, A.S.G. Mr. Gurmeet Singh Makker, AOR Mr. Sharath Nambiar, Adv. Mr. Vinayak Sharma, Adv. Mr. Rajat Nair, Adv. Mr. Kanu Agrawal, Adv. Mr. Shashank Bajpai, Adv. Mr. Ishaan Sharma, Adv. Ms. Avni Singh, Adv. Mr. Jitin Chaturvedi, AOR Mr. K.M Nataraj, A.S.G. Mr. Sharath Nambiar, Adv. Mr. Vinayak Sharma, Adv. Mr. Rajat Nair, Adv. Mr. Kanu Agrawal, Adv. Mr. Shashank Bajpai, Adv. Mrs. Priya Mishra, Adv. Mr. Amrish Kumar, AOR Mr. Mukul Rohatgi, Sr. Adv. Mr. Vipin Sanghi, Sr. Adv. Mr. Balbir Singh, Sr. Adv. Mr. Arvind Nayar, Sr. Adv. Mr. Simranjeet Singh, Adv. Mr. Gautam Talukdar, AOR Mr. Raushal Kumar, Adv. Ms. Apurbaa Dutta, Adv. Ms. Neha Gupta, Adv. Ms. Smita Jain, Adv. Mr. Karan Jain, Adv. Mr. Rishabh Pant, Adv. Mr. Nikhil Rohatgi, Adv. Mr. Rohit Gandhi, Adv. Mr. Naman Tandon, Adv. Mr. Hargun Singh Kalra, Adv. Mr. Akshay Joshi, Adv. Mr. Rahul Kumar, Adv. Mr. Sagar Roy, Adv. Mr. Manoj Kumar Chowdhary, Adv. Ms. Vanshaja Shukla, AOR Ms. Ankeeta Appanna, Adv. Mr. Siddhant Yadav, Adv. Ms. Mrinmoi Chatterjee , AOR Mr. Amarjit Singh Bedi, AOR
Advocate Appeared:
For the Petitioner: Mr. P.S. Patwalia, Sr. Adv. Mr. Prabhas Bajaj, Adv. Mr. Priyanshu Tyagi, Adv. Mr. Rishav Rai, Adv. Mr. Amarjeet Singh, AOR
For the Respondent: Mr. K M Nataraj, A.S.G. Mr. Gurmeet Singh Makker, AOR Mr. Sharath Nambiar, Adv. Mr. Vinayak Sharma, Adv. Mr. Rajat Nair, Adv. Mr. Kanu Agrawal, Adv. Mr. Shashank Bajpai, Adv. Mr. Ishaan Sharma, Adv. Ms. Avni Singh, Adv. Mr. Jitin Chaturvedi, AOR Mr. K.M Nataraj, A.S.G. Mr. Sharath Nambiar, Adv. Mr. Vinayak Sharma, Adv. Mr. Rajat Nair, Adv. Mr. Kanu Agrawal, Adv. Mr. Shashank Bajpai, Adv. Mrs. Priya Mishra, Adv. Mr. Amrish Kumar, AOR Mr. Mukul Rohatgi, Sr. Adv. Mr. Vipin Sanghi, Sr. Adv. Mr. Balbir Singh, Sr. Adv. Mr. Arvind Nayar, Sr. Adv. Mr. Simranjeet Singh, Adv. Mr. Gautam Talukdar, AOR Mr. Raushal Kumar, Adv. Ms. Apurbaa Dutta, Adv. Ms. Neha Gupta, Adv. Ms. Smita Jain, Adv. Mr. Karan Jain, Adv. Mr. Rishabh Pant, Adv. Mr. Nikhil Rohatgi, Adv. Mr. Rohit Gandhi, Adv. Mr. Naman Tandon, Adv. Mr. Hargun Singh Kalra, Adv. Mr. Akshay Joshi, Adv. Mr. Rahul Kumar, Adv. Mr. Sagar Roy, Adv. Mr. Manoj Kumar Chowdhary, Adv. Ms. Vanshaja Shukla, AOR Ms. Ankeeta Appanna, Adv. Mr. Siddhant Yadav, Adv. Ms. Mrinmoi Chatterjee , AOR Mr. Amarjit Singh Bedi, AOR
The court emphasized accountability for misleading advertisements affecting public health and directed ministries to examine their enforcement actions.
Headnote:(A) Drug and Magic Remedies (Objectionable Advertisements) Act, 1954 - Drug and Cosmetics Act, 1940 - Consumer Protection Act, 1986 - Misleading advertisements by FMCGs/Pharmaceutical Companies affecting public health - Court examines the need for accountability and compliance with relevant laws to protect consumers, particularly vulnerable populations. (Paras 5, 6, 7)
(B) Implementation of laws - The court emphasizes the necessity for all relevant ministries to take action against misleading advertisements and ensure compliance with the law, highlighting the importance of consumer protection and public health. (Paras 5, 8)
(C) Ethical standards - The court notes the need for the petitioner-Association to address complaints regarding unethical practices among its members, ensuring trust and integrity in medical recommendations. (Paras 9, 10)
Act Referred
DRUGS AND COSMETICS RULES: R.170
Legal Category Hierarchy
Table of Contents
2. Proposed contemnors submitted unqualified apologies for lapses in conduct. (Para 1 , 3 )
3. Misleading advertisements harm vulnerable groups — non-enforcement of existing rules despite non-deletion is improper — unethical practices by medical association members require scrutiny. (Para 5 , 6 , 9 )
4. Systemic examination of the implementation of drug and consumer protection laws is necessary to prevent public health risks arising from misleading advertisements. (Para 5 , 7 )
5. Impleadment of relevant Union Ministries, State Governments, and National Medical Commission — direction to file affidavits on enforcement of drug and consumer protection laws. (Para 7 , 8 , 10 )
6. What is the court's concern regarding misleading advertisements by pharmaceutical and FMCG companies?
The court observed that such advertisements mislead the public and adversely affect the health and well-being of vulnerable groups, including babies, children, women, senior citizens, and the sick. (Para 5 )
7. What issue did the court identify regarding Rule 170 of the Drugs and Cosmetics Rules, 1945?
The court noted that while Rule 170 had not been deleted, a Ministry of AYUSH letter had directed authorities not to initiate action under it, effectively suspending its enforcement. (Para 6 )
8. How does the court intend to address the lack of accountability for misleading advertisements?
The court impleaded multiple ministries and State Governments to examine steps taken to prevent the abuse of the Drug and Magic Remedies Act, Drugs and Cosmetics Act, and Consumer Protection Act. (Para 7 , 8 )
9. What observations did the court make regarding the conduct of the petitioner-Association's members?
The court noted complaints of unethical acts, including prescribing prohibitively expensive medicines and recommending unnecessary investigations for extraneous considerations. (Para 9 )
ORDER :
1. Mr. Mukul Rohatgi, learned Senior counsel appearing for the proposed contemnors submits that some advertisements tendering unqualified apologies have been published in the press by the proposed contemnors for the lapses on their part, only yesterday. It is submitted that the same have been collated and shall be filed during the course of the day with copies furnished to learned counsel for the parties.
2. Needful shall be done within two days.
3. It is further stated that additional advertisements shall be published by the proposed contemnors tendering an unqualified apology for the lapses on their part within this week. As and when the said advertisements are issued and copies filed, the same shall be considered and appropriate orders passed.
4. List on 30th April, 2024, at the top of the Board. The proposed contemnors shall continue to remain present on the next date of hearing.
5. We are of the opinion that the issue relating to implementation of the relevant provisions of the Drug and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Rules, Drugs and Cosmetics Act, 1940 and the Rules and the Consumers Protection Act, 1986 and the Rules, need a closer examination in the light of the grievances raised by the petitioner-Association, not just limited to the respondents before this Court, but to all similarly placed FMCGs/Pharmaceutical Companies who have been issuing misleading advertisements relating to the products manufactured and marketed by them and taking the public at large for a ride, in particular, adversely affecting the health and well-being of babies, young children, women (including lactating and pregnant women), senior citizens and the sick and infirm, who have been consuming the products on the basis of the said misrepresentations.
6. Further, Union of India is called upon to explain the letter dated 29 th August, 2023 issued by the Under Secretary, Ministry of AYUSH, Government of India addressed to all States/UT Licensing Authorities and Drug Controllers of AYUSH informing them that the Ayurvedic Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) in its meeting held on 25th May, 2023, has recommended to proceed with the final Notification omitting Rule 170 of the Drugs and Cosmetics Rules, 1945 and its related provisions and in the meantime, all authorities have been directed not to initiate/take any action under Rule 170 . Notably, in all this duration, the said Rule has not been deleted and at the same time, it is not being enforced on the strength of the aforesaid letter.
7. Having regard to the number of misleading advertisements being published/displayed with little/nil accountability on the part of the manufacturers, promoters as also the press/electronic media, besides the Ministry of AYUSH, it is considered necessary to implead the Ministry of Consumer Affairs, Ministry of Food and Public Distribution, Ministry of Information and Broadcasting and the Ministry of Electronics and Information Technology to examine the steps taken by each of the aforesaid Ministries to prevent the abuse of the Drug and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Rules, the Drug and Cosmetics Act, 1940 and the Consumer Protection Act, 1986. All the State Governments/UT Licensing Authorities being necessary and proper parties shall also be impleaded as correspondents in the present petition.
8. Mr. K.M. Nataraj, learned Additional Solicitor General who is appearing virtually, states that his briefing counsel is accepting notice on behalf of all the Ministries referred to hereinabove. The said Ministries shall file their respective affidavits explaining the action taken by them to prevent misuse/abuse of the aforesaid statutes along with the relevant data from the year 2018 onwards and the action taken on receiving such complaints either on the Grievances Against Misleading Advertisements portal (GAMA) or from any other source.
9. Coming to the petitioner-Association, we are of th
