The beans have been spilt. This is what happens when top bureaucrats have difference of opinion and bring their differences to the streets. The Drug Controller of India, New Delhi found out that the State Drug Controller of Tamil Nadu, had given licenses to manufacture Fixed Dose Combinations (FDCs) of drugs that he himself would have objected to. What was initially a war of words between the two bureaucrats soon ended with litigation in the High Court of Tamil Nadu.

In a big blow to the Drug Controller of India’s efforts to phase out FDCs of drugs from the Indian market, the court has given a stay on a petition filed by Confederation of Indian Pharmaceutical Industries (CIPI), in November 2007.

Combination of drugs

We need to get to some medical jargons before understanding this issue. What are FDCs? FDCs are combination of two or more active drugs presented to the patient (or consumer) in a single dosage form. An example: Paracetamol is a drug used to treat fever and Ibuprofen is a drug used to treat inflammation. When these two drugs are combined and given in a single dosage form it is known as FDC. Text books of medicine or of pharmacology or the medical scientific community do not accept this combination and so this is known as “irrational combination.” 

 And there are several such FDCs in the Indian market! The Drug Controller of India has objected to around 300 FDCs (market worth around Rs 3,500 crore) that the State Drug Controller of Chennai has cleared by giving manufacturing permission to various drug companies. 

A group of public health experts who have examined this issue in depth say that there are several such unscientific drug combinations in the Indian market. For example, an analysis of the top-selling 300 drugs showed that that 60 per cent of them are irrational. Further FDCs which account for more than 90 per cent of the total retail sales in India do not find any mention in standard textbooks of medicines.

The list includes several categories, apart from common pain-killers, of drugs like many FDCs of antibiotics, antimicrobials and antidiarrhoeal. Even drugs needed to treat the common conditions like anemia and cough do not confine to standard scientific guidelines and thus are irrational FDCs. The World Health Organisation explicitly mentions that “Indeed, it can be argued that the very existence of an FDC discourages adjustment of doses to the patient’s need”.

FDCs are not new in the Indian market but what is worrying is that initially it started with few dozen drugs and then they flooded the market in the next two decades.

Need for legislation

Responding to the pressure for newer products, drug companies used to invent combinations of two or more drugs, often launched without an assessment of their therapeutic benefits.  In response the Health Ministry has amended the Drugs & Cosmetics Act in 1988 to address this new development.

So the rule 122 (E) of the Drugs & Cosmetics Act requires submission of all relevant pre-clinical and clinical trial data for FDC drugs. In addition, the amendment makes it abundantly clear that the state Drug Controlling authorities have no power to issue licences for FDCs. Most of the State Drug Controllers in any case do not have the expertise or facilities to assess the merits and demerits of drug combinations.

Not all FDC’s are bad. In fact FDCs have certain advantages in certain specific and selected situations. Indeed out of the total number of 347 essential drugs mentioned in the latest list of essential medicines by WHO (March 2007), only 26 (7.5 per cent) are acceptable FDCs. Apart from these most of the FDCs are not only unnecessary but are big public health problems.

India needs to take a lesson from its neighbouring Bangladesh. As a result of Bangladesh Drug Ordinance 1982, several hundreds of FDCs were removed from the market. This ordinance was based on the World Health Organisation’s essential drug list and recommendations. There is an unrgent need in India too to clear the mess. Will it happen? Only time will tell.