What are FDC drugs? Which medicines are banned in India?

Like me if you are asking ‘what are FDC drugs’, then read on. On the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government has recently banned 14 fixed dose combination (FDCs) drugs including Nimesulide and Paracetamol dispersible tablets and Chlopheniramine Maleate and Codeine syrup.

A notification by the Health Ministry said that the Central Government “is satisfied that it is necessary and expedient in the public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country.”

The expert committee said that there is “no therapeutic justification for this FDC (fixed dose combination) and the FDC may involve risk to human beings. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable.”

What are FDC drugs and what are ‘irrational’ FDCs?

FDC drugs are those drugs which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. Further, FDC is also defined as following – “An FDC product is when 2 or more drugs are combined physically into one preparation such as a tablet or pill.”

What are ‘irrational’ FDCs drugs?

When drugs are combined in a way that is medically inappropriate and ineffective, they are called “irrational FDCs”. There is widespread ‘irrational’ use of FDCs.

In 2016, the government had announced the ban on the manufacture, sale and distribution of more than 300 drug combinations after an expert panel, set up at the behest of the Supreme Court had stated they were being sold to patients without scientific data. The currently banned 14 FDCs are part of those earlier banned drug combinations.

The List of Banned Drugs in India are (the FDCs combinations drugs includes):

  • Nimesulide + Paracetamol dispersible tablets
  • Chlopheniramine Maleate + Codeine Syrup
  • Pholcodine +Promethazine
  • Amoxicillin + Bromhexine
  • Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
  • Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin
  • Salbutamol + Bromhexine

Here is the entire list of drugs banned by MINISTRY OF HEALTH AND FAMILY WELFARE.

Why FDCs are not always useful?

FDCs are not always beneficial or safe for various scientific reasons. When combined as FDCs, some medications can result in a lessened therapeutic benefit. Sometimes these combinations exhibit a different safety profile, contrary to what could be extrapolated based on the actions of these medicines when used individually.

This aspect demands extreme caution from the pharmaceutical companies, careful checks from the regulatory agencies, and due diligence on the part of healthcare providers.

Factors for explosion of FDCs

What are FDC drugs and why are they used so liberally? The disproportionate growth of both – FDCs and ‘irrational’ FDCs in India was fuelled by various factors prevalent across the spectrum of the pharmaceutical ecosystem.

Key factors include aggressive commercial and at times irrational outlook from the pharmaceutical companies, lapses of regulatory agencies, negligence among medical practitioners and pharmacists, and ignorance of both rural and urban public taking non-prescription-based medications either through unqualified practitioners or as self-medication.

Even though the FDCs have been documented in Indian market since the 1960s, efforts to regulate them started in 1988, following a revision of rules under the Drug & Cosmetic Act, 1940.

FDCs – Issues and challenges

While 1,292 FDCs have been approved officially from 1961 to mid-2018 by the CDSCO as Central Licensing Authority (CLA), their actual numbers in the Indian market – including those approved by several State Licensing Authority (SLAs) – is estimated to be around 6,000, says a study on Fixed dose drug combinations: Issues and challenges in India by Yogendra Kumar Gupta, Suganthi S Ramachandran. Notwithstanding with the basic principle of formulating FDC, the Indian medicine market has become the world leader of FDCs.

The study by Gupta-Ramachandran further says that due to the difficulties in developing new chemical entities, the pharmaceutical industry finds it easier to develop FDCs. India is primarily the market of generic drugs. As the patent expires, the intense competition among multiple manufacturers tempts them to give the product a new look claiming multiple advantages without scientific validation.

By the Drug Price Control Orders 2013, the drugs included in the NLEM were brought under price control by the National Pharmaceutical Pricing Authority of India. To evade the price control, some companies reformulate the individual drugs into an FDC. This loophole has since been checked.

Thus, frequent prescribing of FDCs and the near absence of adverse drug reaction reporting system in India legitimize this faulty practice. The high sales turnover and high prescription trend from Medical Colleges, Primary Health Centers, and general practitioners are often projected as their rationality, safety, and efficacy.

Who approves licenses for FDCs?

The Parliamentary Standing Committee on Health and Family Welfare in its 59th report pointed out that some State Licensing Authority (SLA)s have been issuing manufacturing licenses for FDCs without prior clearance from Drugs Controller General of India (DCG).

Ideally, the Central Drugs Standard Control Organization (CDSCO), after due examination of data on rationality, safety, and efficacy, issues approval for FDCs. On the basis on this, the SLA gives the manufacturing and marketing permission.

Incidentally, in the past, SLAs issued the license to manufacture and market without asking for no-objection from CDSCO. Thus, the efficacy, safety, and rationality of such FDCs remain questionable. This “disconnect” between the CDSCO and SLAs has precipitated a roadblock in the action against irrational FDCs. Hope you got the answer to what are FDC drugs!