More Ban on IRRATIONAL Fixed Dose Combinations ..More legal battles ....!!

The ban had taken the pharma industry by surprise. What's next then ?

More Ban on IRRATIONAL Fixed Dose Combinations {FDC} ..More legal battles ....!!

90 % of those which have been affected by the ban are domestic drug units. Taking into account various taxes viz. sales tax , excise duty, VAT  paid by the chemists, cost of packing materials, labour, logistics, the losses incurred by the pharma industry will reach Rs.20,000 crore as per reliable sources . 

The shortfall in revenue of pharma industries will subsequently lead to retrenchment of staff.  It is a national loss and the government has remained silent over compensation of wholesalers, retailers who stocked these drugs.

The problem of FDCs has been there for quite some time in the country. The companies themselves are some of those banned drugs are being sold in the country for the last 30 years. A paper published in PLOS Medicine notes that India is flooded with such risky FDCs. The paper is based on a study done in just four therapeutic areas including analgesia, anxiety/ depression and psychosis. Most of the Fixed Dose Combination formulations available in India [in the four therapeutic areas studied] were unavailable in either UK or the U.S.

All in all, 344 is just the tip of the iceberg

DCGI is currently reviewing another 619 medicines out of the total 963 FDCs found irrational following the Union health ministry's ban on 344 fixed dose combination (FDC) drugs including cough syrups,painkillers, anti-diabetic, respiratory and gastro-intestinal medicines.

The pharma retail market may witness more and more  Fixed Dose Combinations going off their shelves as DCGI may ban them in the coming months. The irrationality of the FDC was assessed based on a blind process which could determine that the ingredients used in the FDC proved efficacious and safe for the patients and the FDCs were banned taking into consideration the health prospects of the common man with focus on antibiotic resistance.

Many of the Fixed Dose Combinations  did not face a similar fate and were cleared based on the scientific documentary evidences. Actions from the DCGI office was taken on companies who did not register their FDCs with the DCGI and did not show up with the requisite documentary evidence to claim the safety and efficacy of the respective FDC in question

India's drug pricing watchdog National Pharmaceutical Pricing Authority (NPPA) has moved in to back the health ministry. NPPA has also brought under the lens third-party drug makers and pharma companies that outsource to them to check irrational FDCs and spurious drugs. Many popular cough syrups, painkillers and antibiotics are Fixed Dose Combination brands. FDCs are cocktail drugs that contain two or more therapeutic ingredients in one dose.

Recently NPPA has taken cognizance of the fact that no irrational FDCs should get a price fixed by NPPA  and get legitimised in an indirect manner. NPPA is concerned only with the pricing part (of this issue), and  not declaring these Fixed Dose Combinations rational or irrational

Why the difference of Opinion among Judges ?

In the meantime differing with the Delhi High Court interim order lifting the ban on fixed dose combination medicines of some pharma companies, the Madras High Court  refused to interfere with the Centre's order prohibiting their sale and manufacture in India. A bench of Chief Justice Sanjay Kishan Kaul and Justice M M Sundresh declined to stay the Centre's March 10 notification banning over 344 FDC drugs by refusing to concur with the Delhi High Court's interim order granting relief to some major pharmaceutical companies against the government decision. On consideration of the matter, they disagreed with the view of the single judge of the Delhi high court and did  not  pass an all-encompassing order.

With two high courts differing on the issue, there is a likelihood of the matter reaching the Supreme Court.

It is not the court but a dialogue which can resolve the stalemate.

Industry, the drug regulator and the expert committee must work together to find an amicable solution without compromising patient safety and interest. . Unfortunately, the developments  has done immense damage to all the three agencies .

Association stance to be pro Industry

The Pharma Association contended that the Centre had unilaterally and arbitrarily prohibited the sale and manufacture of the Fixed Dose Combinations produced for decades, without complying with process of natural justice. The division bench of the Madras High Court did not agree with the contention of senior counsel  who had appeared for the petitioners, that identical relief as granted by the Delhi High Court be considered in the matter.

Healthcare majors, including Cipla, Lupin, Wockhardt, Glaxosmithkline and Mankind Pharma, Dr Reddy's, Alkem Laboratories, Ajanta Pharma, Khandelwal Laboratories Pvt Ltd, Micro Lab Ltd, FDC Ltd, Coral Laboratories Ltd and Eris Lifesciences Pvt Ltd were  granted interim relief by the Delhi High Court .The court passed the same order as was issued in the pleas filed by the eight other companies, including Pfizer, Procter and Gamble (P&G), Glenmark and Reckitt Benckiser .Till date, the interim stay order of the High Court is being enjoyed by 22 companies which also include Abbott Healthcare, Alembic Pharmaceuticals, Piramal Enterprises and Macleods Pharmaceuticals.

 Although 344 combination drugs have been banned, the number of brands or products is higher because many companies own and market more than one combination of these FDC drugs. Most of these banned products are related to pain killers, cough and cold. Also there are brands in categories such as syrups, ointments and lotions. The number of such brands could increase as the identification process progresses.

 IDMA has 950 members and all of them have been affected. Most of the companies have stopped production of combination drugs after the ban.

Govt open for review & revisit the banned list

The Department  had the best of scientists on board to study the effects of these drugs & tried to bring objectivity to the issue by roping in the best of scientists to study the effects. The government is likely to review the list of 350-odd banned drugs. They are open to review and re-visit the banned list. Companies can go to ministry of health and family welfare with scientific proofs to back their drugs.

The ministry had given a fair chance to companies to put forward their point by putting up public notices and show cause notices, and it would be their  duty to re-look decisions if they are backed by evidences. The government has decided to prohibit manufacturing and sale of these medicines because they were found to be “irrational” without any therapeutic efficacy and use. The health ministry had received about 7,000 applications in 2013 from manufacturers of Fixed Dose Combinations for proving their safety and efficacy.

The ministry constituted a committee  which reviewed the applications under four categories — irrational, rational, those requiring further deliberation and those requiring generation of additional data.

Under the irrational category, there were 963 Fixed Dose Combinatios, out of which 350 have been announced, and the list has been dismantled. Govt have moved to the ‘require further deliberations’ category, where the final list is expected to come in six months as per official at the Central Drugs Standard Control Organisation (CDSCO)

The DGCI has now submitted the “B” list to the Kokate committee. Out of the 1,200 FDCs mentioned in the list, 8-10%, i.e. around 120 drugs, would fall under the banned category .Each FDC has at least 5 to 10 brands in the market, which means around 1,200 more drugs are likely to be banned. According to government estimates, the ban which impacts over 2,700 branded drugs will lead to a loss of over Rs 7,000 crore for the industry. The domestic pharma industry currently has a market size of Rs 1 lakh crore. At present, there are more than 64,000 different formulations being manufactured and sold through pharmacies. Around 5,000 manufacturers, 8,000 brands, 75,000 wholesalers and 7 .5 lakh drug retailers are affected. 

All India Organisation of Chemists and Druggists (AIOCD), the association representing about 750,000 medicines sellers across India, has approached  to the Drug Controller General of India (DGCI) citing the possibility of closing their shops for at least 30 days and will force them to shut down their shops and find out different brands of banned formulations available with us... followed by return of the stock to the concerned distributor and manufacturer.

Chemists have also urged the government to advise all concerned state authorities not to take any action against traders. The notification by the government impacted over 5,000 drugs available in the market..Not only it would be very difficult for traders to find out brands of these molecules manufactured by other makers, it would be very difficult to stop sale of these products with immediate effect..

Is my cough syrup safe ?

As per some Industry experts of  a leading herbal drug  firm believes the government’s action has boosted consumer awareness about the ‘harmful’ contents of cough syrup.They may now check the ingredients before making the purchase.To catch this new consumer, companies will soon draft strategies and arm their medical representatives with new pitches to push their non-codeine-based brands via doctors.

As per IMS Health, a research company, cough preparation was the highest selling therapeutic subgroup last year in value terms with significant growth of 35% on monthly basis. Only 13 of the 80-odd cough syrup brands available in the Indian market are over the counter as per the latest Nielsen data.The market is highly fragmented, where no brand including Phensedyl, Corex and Benadryl has more than 10% of market share. Popular herbal cough syrup, Honitus, commands 2% market share.The brands to benefit  includes Honitus ,Kanti Herbal, Torex, Koflet among others.Companies are expected to launch more variants.

The strategy of popular ones will be to protect the market share they have captured over the years. For others, it is an opportunity to wage war and gain market share. However, Phensedyl and Corex both  received interim stay from the high court against the government’s notifications and will continue to sell products until  the legal battle is over and if they lose.. That's for time to say.

The ban will have a cascading effect on growth of pharma industry. It will not only affect profitability of the drug companies but also weaken their research and development capability.