Chronicles of FDC Ban in India

Indian Pharma Sector often boasts about being known as Pharmacy of the World. There is no doubt that Indian pharma sector has grown by leaps and bounds. In the rush of achieving more and more it has been observed that somewhere the regulatory aspects w.r.t. safety, efficacy and quality of drugs being manufactured are compromised. This issue has been observed especially w.r.t. various Fixed Dose Combinations (FDC) being manufactured and marketed in the country.

Fixed Dose Combinations popularly known as FDCs are a cocktail of two or more active drugs formulated in a single unit dose. They are very popular among physicians for ease of prescription, among patients for lower cost and among pharma companies to have a varied portfolio of drugs.

However, the FDCs are often criticized as a tool for pharma companies to circumvent price control. Pharma companies prefer to market FDCs that are not under price control rather than single-ingredient drugs under price control.

Apart for price control FDCs are considered as quick-fixes for pharma manufacturers as it is far cheaper and quicker to combine existing active ingredients to make new products than to discover new medicines and manufacture them separately. In rush of delivering new and unique FDCs, the manufacturers do not pay the required attention for generating the clinical safety and efficacy data. Hence, many irrational and sometimes even absurd combinations are available in the market. These FDCs by the means of ‘innovative’ and ‘sophisticated’ marketing strategies found their way right on to our shelves.

Central  Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health and Family Welfare, Government of India has taken many steps to control this menace and vide various notifications has banned several FDCs on the grounds of irrationality and unproven safety and efficacy. However, it is pertinent to mention that many of these notifications were challenged by the way of writ petition in various courts across India.

Due to this, pharma manufacturers find themselves confused as which of the combinations are currently banned and which of the combinations are currently not banned.

In this article, we shall be trying to clarify the same by providing the data in the tabular form for ease of understanding.

A. Fate of FDC those were banned vide notifications dated 10.03.2016 (344 FDC) and 08.06.2017 (05 FDC)

Government of India had prohibited the manufacture for sale, sale and distribution for human use of 344 + 5 FDCs (total 349 FDCs) vide various notifications dated 10.03.2016 and 08.06.2017. However, in compliance with the directions given by the Supreme Court of India in its judgement dated the 15th December, 2017 in Union of India and Anr. v/s Pfizer Ltd. and Ors. Civil Appeal No. 22972 of 2017 (Arising out of SLP (c) No.7061 of 2017), the matter was examined by Drugs Technical Advisory Board (DTAB) constituted under section 5 of the Drugs and Cosmetics Act, 1940 (23 of 1940) which furnished its report on the 31st July, 2018.

The DTAB evaluated the combinations and agreed with the report of the expert committee for 328 FDC. The expert committee had previously recommended the ban of 349 FDCs.

Hence, on the basis of the recommendations of the said Expert Committee and Drugs Technical Advisory Board, the Government of India reconfirmed the prohibition of manufacture for sale, sale and distribution for human use of following FDCs vide their notification dated 07.09.2018. Remaining 21 FDCs have been kept out of the list and may be considered as unbanned. This is to be noted that Government of India vide notification no. 697(E) dated 05.02.2019 had revoked the ban on FDC of Paracetamol + Caffeine + Phenylephrine + Chlorpheniramine. Hence, currently final tally stands at 327 banned and 22 unbanned (Out of 22 banned 6 FDC are classified as for restricted use).

B. Fate of 294 FDC those were banned in the year 2007

Government of India had prohibited the manufacture for sale, sale and distribution for human use of 294 FDC in the year 2007. However, the manufacturer associations got stay from the Hon’ble Court of Madras on the directions issued in the matter. The matter was then placed in Drug Technical Advisory Board (DTAB) in the 56th meeting dated 16.01.2008. A sub-committee was constituted by DTAB to examine these FDCs. Accordingly, the sub-committee examined these FDCs and submitted its report to the DTAB. DTAB in its meeting held on 16.02.2015 agreed with the recommendations of Sub-committee of DTAB. The Hon’ble Supreme Court as per its judgement dated 15.12.2017 had accepted its recommendations.

The current status of these banned 294 FDCs is as follows:

Presenting the above lists we have tried our best to provide an update on the FDC ban in India in a more palatable way.

In case of any inputs regarding further improvement or clarity in this article or any further update on FDC ban, you may write to us on vaayath@gmail.com.

Note: The above data has been compiled using various current notifications issued by Govt. of India. The same may be referred to the official website of Central Drugs Standard Control Organization (CDSCO). However, list is dynamic and current effective notifications shall be referred.