Road Ahead For Indian Pharma Companies Following Govt Clampdown

FDCs (fixed dose drug combinations) are a combination of two or more active drugs in a single dosage form. According to USFDA, combination product as ‘a product composed of any combination of a drug. It is widely accepted that most drugs should be formulated as single compounds. Fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement and when the combination has a proven advantage over single compounds.’

Demerits of FDCs:

*Dosage alteration of one drug is not possible without alteration of the other drug.

*Increased chances of adverse drug effects and drug interactions compared with both drugs given individually.

*Irrational FDCs expose patients to unnecessary risk of adverse drug reactions.

*Imprudent use of antibiotic FDCs can rapidly give rise to resistant strains of organisms.

*It is indeed its widely being deemed positive by the medical fraternity in India in the long run a change from their previous hard stand on the issue.

Pharmaceutical manufacturers, however, continue to reap the benefits of huge sales, and therefore continue to promote combinations with vigour. In India, a variety of FDCs combinations are easily available. These combinations are an easy way to sell two drugs when one (or even none) may be needed for the patient. The ‘combined’ pills are marketed with slogans like ‘Ibuprofen for pain and Paracetamol for fever’.

Positives of FDCs:

On a positive side FDCs, according to WHO, such combinations of drugs are being used in the treatment of a wide range of conditions and are particularly useful in the management of HIV/AIDS, malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.

Government Action

Finally taking stock of the matter government decided to ban 344 FDCs following recommendations of expert committee headed by Dr C K Kokate, former president of Pharmacy Council of India. FDCs have been highly popular in the Indian pharmaceutical market over the past few years.

Global Practice

Globally developed economies of US and Europe have stopped the approval of FDCs as they are perceived to cause long term damage to patients consuming the drug. Fixed dosage drugs are therefore, not approved anywhere else in the world except for few developing markets. Thus, this was a step taken in the right direction.

Rationale behind GOI banning FDCs

 The government through Drugs Controller General of India (DCGI) banned 344 fixed dose combination (FDC) drugs, including several antibiotics and analgesics, saying that a government-appointed panel of experts had found the combinations lacked ‘therapeutic justification.’ According to the government appointed expert committee, noted that "it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use" of the drugs.

Banned Drugs and Companies Hit:

Health ministry banned 344 fixed dose combination (FDC) drugs including painkillers, anti-diabetic, respiratory and gastrointestinal medicines. According to the Pharmaceutical Wholesalers Association (PWA), there might be 7 per cent of domestic drug market which would in turn loss of Rs 7000 crore. Considering excise duty, VAT, sales tax paid by the chemists, cost of packing materials, labor, logistics, the forthcoming losses incurred by the pharma industry will reach to Rs 20,000 crore. Out of the total banned drugs 90 per cent have been affected are domestic drug units.

There is large number of companies affected due to the recent FDC ban. The list includes Pfizer, Glenmark Pharmaceuticals, Procter and Gamble (P&G) and Cipla, Glaxo Smithkline, Reckitt Benckiser, Abbott Healthcare, Piramal, Lupin, Mankind Pharma and Wockhardt, Alembic Pharmaceutical, Ajanta Pharma, Dr. Reddy's Laboratories, Alkem Laboratories, Coral Laboratories.

Government ban on FDC drugs includes top brands viz. analgesics Zerodol and Sumo, dermatology drug Panderm Plus, anti-diabetic medicine Tripride, and gastro-intestinal drug Zenflox, besides cough syrups Phensedyl and Corex.

Government’s decision to ban FDC drugs has impacted more than 400 small and big pharmaceutical companies in Gujarat. The ban covers more than 2000 brands manufactured by these firms. Consequences of the actions has led to immediate removal of famous brands like ‘Vicks’, Corex cough syrup, D’Cold etc from the shelves. In the near term, people dependent on these branded drugs may have a problem but on a longer term horizon it augurs well for the patients as they would not be exposed to harmful effects on the drugs.

More such ban?

Indian Health Ministry took a significant step as ban of about 344 drugs, there are about 1200 FCD drugs has been sent by Drug Controller General of India (DGCI) to the panel. Right now, the recent banned drugs case is in Delhi High Court.

On March 10, the government’s banned FDC drugs, extending to about 6000 brands quoting health risks, based on a report by a six-member committee headed by Chandrakant Kokate. The Kokate panel submitted its report on January 20, 2015 and termed 963 FDCs ‘irrational’, posing health threats.

Though there were 963 drugs categorised under irrational one, out of which about 344 drugs banned and remaining list of drugs has been kept aside. Meanwhile, Central Drugs Standard Control Organization (CDSCO) moved remaining drugs to the category as ‘require further deliberations’ and final list would be available in coming six months.

The DGCI has now submitted the ‘B’ list consisting 1200 FDCs mentioned in the list to the Kokate committee. Out of total B list around 100 plus drugs would fall under the banned category.

The World Health Organisation had approved only 350 formulations of fixed dose combinations to treat prevalent diseases. Meanwhile, many of the pharmaceuticals companies developed more than 6000 combinations which is quite very high compared to the approved combinations.

FDC drugs have more side effects than normal components. However, many of the doctors have viewpoint as FDC drugs are advantages being in the combination format rather than in single components.

The FDC scrutiny panel appointed by the government has found that these medicines involve risk to human being. The panel also pointed that there are various benign alternatives available in the market.

Many doctors always try to give drugs to patients considering combination drugs instead of single drugs. After the government’s FDC ban made hospital community in ambiguous mode as they are confused over the implementation of banned drugs.

According to Kokate panel, there will not be any material impact of banned drugs. As there are more than one lakh formulations are available in the market. The similar formulation of drugs will cater need of customers and hospitals.

There is a law that prohibits pharmacists for selling drugs to customers without Doctor’s prescription. The government has to ensure that banned drugs which should not be sold in the market.

Considering overall pharmaceutical market, there will be no impact if they are banned as there are over one lakh formulations available in the market. Pharmaceutical companies those which have exposure towards the FDC ban moved in the Delhi High court.

Therefore, it is quite clear from the fact the India being one of the world’s major generic drugs exporter needs to refit the entire structure and bring in more transparency and stringent laws in order to deal with such issues.

Unapproved FDCs and the ones posing risk to patients at large should be banned with immediate effect and patients transferred to appropriate single drugs. Public health should be of prime concern to the authorities, not manufacturers' commercial concerns, should be the focal point of the regulation. But it has been often noticed that, business interest comes first and citizen’s safety and health takes the backseat.

Clarity needs to emerge sooner or later on this important issue as investors in these pharma companies lose out money due to banned as there already battered share prices takes a further beating in the day’s to come. The government’s recent ban on FDCs coupled with the impact of linking drug prices to wholesale price index (WPI) and bringing a larger number of medicines under price control has wiped out substantial market capitalization of the entire sector at large and ultimately negatively hurting the investor.

Indian medical experts and drug manufacturer alongside regulatory authorities should come together and work towards a comprehensive drug policy for India. With a robust and clear legislation would help in achieving the desired objectives and would also add more value to the India’s claim of being one of the major’s hubs for drug manufacturing in the country.