HCFI Representation for formulation of law on OTC drugs accepted as PIL and Govt. given time for reply

On 24.08.2018, Hon’ble Chief Justice of Delhi High Court had accepted and converted the representation filed by Dr KK Aggarwal, Padma Shree Awardee and National President of Heart Care Foundation of India (HCFI) into a Public Interest Litigation (PIL) on the issue of formulation of law on Over-the-Counter (OTC) drugs in India. Notices were issued to Union Government, Government of NCT of Delhi, Drug Controller General of India(DCGI), National Pharmaceutical Pricing Authority etc. in the said PIL.

On Wednesday i.e. 14.11.2018, the said PIL was listed for hearing and all the respondents have been granted 4 weeks’ time to file their counter affidavits / replies.

The Drugs and Cosmetics Act, 1940 (hereinafter referred to as “DCA 1940”) was passed and modified by the Central Government with main object to regulate the import, manufacture distribution and sale of drugs (and cosmetics) vide amendment made in Section 2 of DCA 1940 in the year 1962 w.e.f. 27.07.1964. They came into effect from 21.12.1945.  Later, Drugs and Cosmetics Rules, 1945 (hereinafter referred to as “DCR 1945”) were notified by the Central Government under powers given in Section 6(2), 12, 33 and 33(N) of DCA 1940. They came into effect from 10.04.1940.

In the above DCA 1940 read with DCR 1945, there are various schedules i.e. Schedule G, H, H1 and X, which contain details and particulars of modern/allopathic medicines which cannot be sold without prescription by doctor i.e. registered medical practitioners as defined in Rule 2(ee) of DCR 1945. Similarly, in Schedule E1 of DCR 1945, some Ayurvedic medicines/drugs are mentioned which can be sold only with the prescription of registered medical practitioners as defined in Rule 2(ee) of DCR 1945.

However, the said DCA and DCR does not recognize OTC drugs, which can be sold and purchased by any person without any prescription from the registered medical practitioner.

The term OTC drugs is being recognized in the world at large as these OTC drugs are a critical component in advancing consumer health because they allow people to treat or manage many health conditions conveniently and successfully. Because they enable people to self-treat, OTC medicines save health systems valuable resources and can save consumers time and money.

In this regard, HCFI had filed one RTI Application with National Pharmaceutical Pricing Authority (NPPA), Dept. of Pharmaceuticals and also with DCGI, Ministry of Health and Family Welfare.

In response to the said RTI application, the Directorate General of Health Services (DGHS) had stated that there is no terminology or list of OTC drugs in Drugs and Cosmetics Act, 1940 and Rules, 1945.

Thereafter, HCFI had sent representation to Hon’ble Prime Minister, Ministry of Health and Ministry of Law thereby requesting them to formulate a law thereby recognising OTC drugs in India and also to prepare a list of OTC drugs in India. However, till date the said representations have remained unanswered.

As the request of the HCFI was unanswered, HCFI filed a representation before the Hon’ble Chief Justice of Delhi High Court requesting the Hon’ble Court to treat the said representation as PIL as the same pertains to formulation of law relating to OTC drugs and preparation of list of OTC Drugs in India which is relevant in advancing consumer health because they allow people to treat or manage many health conditions conveniently and successfully.

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