24th August 2018 New Delhi: On Friday i.e. 24.08.2018, Hon’ble Chief Justice of Delhi High Court has accepted and has converted the representation filed by Dr. KK Aggarwal, Padma Shri Awardee and National President of Heart Care Foundation of India (HCFI) into Public Interest Litigation (PIL) on the issue of formulation of law on Over the Counter Drugs (OTC) in India.
The Hon’ble Chief Justice has been pleased to issue notice to Union Government, Government of NCT of Delhi, Drug Controller General of India, National Pharmaceutical Pricing Authority etc. in the said PIL.
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 Ayurveda 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 Over the Counter Drugs (OTC Drugs) which can be sold and purchase 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.
As there the term OTC is not recognised in India, so there are lot of ambiguities. The biggest problem that is being faced is that even for the minor ailments like cold, fever, headache, etc. the public has to visit the medical practitioner as some pharmacist do not dispense any medicine without the prescription of the registered medical practitioner. On the other hand, some pharmacists are selling even the prescription drugs under the garb of non – prescription drugs, said advocate Ira Gupta legal Advisor Heart Care Foundation of India.
In this regard, HCFI had filed one RTI Application with National Pharmaceutical Pricing Authority, Depart of Pharmaceuticals and also with Drug Controller General of India, Ministry of Health and Family Welfare.
In response to the said RTI application, the Directorate General of Health Services had stated that there is no terminology or list of Over the Counter 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 Over the Counter Drugs (OTC) 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, so 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 Public Interest Litigation as the same pertains to formulation of law relating to Over the Counter Drugs (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.
After reviewing, the Hon’ble Chief Justice has been pleased to accept the representation of HCFI to be treated as PIL and on Friday, the Hon’ble Court has issued notice to all authorities.