Fixed Dose Combinations (FDCs) : The confusion is on….

Mohammad Shahid Khan

Syed Ajaz Kazmi

 

With the ban on more than 400 Fixed Dose Combinations ( FDCs) Government had tried to send a strong signal  but the bigger question is that whether the matter has been resolved or more needs to be done in this regard.

Call this as Ignorance of people? Smart publicity by Pharma giants or the sleeping authorities that even after the ban imposed through a gazette notification by Ministry of Health and Family Welfare, people are not still aware of the dangers of Fixed Dose Combinations (FDCs).

The government banned around 329 FDCs in September last year and subsequently, 80 more FDCs were banned in the month of January. Most of the FDCs were banned by saying that these combinations are not just irrational but illogical and dangerous. It was found that there was no long term data available to prove worthiness and safety. Strangely World Health Organization (WHO) has approved only 26 FDCs and here in our country, every other drug is an FDC. Even after the ban on more than 400 FDCs, we still have hundreds of more combination available in the market.

While talking to Taskeen in a telephonic conversation Dr. Gopal Dabade founder member of All India Drug Action Network ( AIDAN) said that pharma companies are acting like starfishes, if you cut one leg another grows. “ Pharma giants are using various methods to remain in the market. They are either approaching courts to get stay orders or they are changing a salt here and there and launching new combinations”, he added. He said that none of the company has ended the brands which have been banned but launched with a new combination. “ The whole effort was to save people from various side effects of these FDCs but somehow it has been a difficult task”, he rued.

He further added that the common public would never be able to know what combination they are consuming as they don’t have the technical abilities. “ Doctors are still prescribing with brand names rather than using the generic names forcing people to buy the medicines of their choice”, he complained.

The announcement of the ban came and went but do people know anything about it? When our reporters went into the field, we found that even the doctors and pharmacist have no clear knowledge about the ban and they don’t even have the list of medicines which are banned. Most of the pharmacist told on the condition of anonymity that they never got any communication or training from the company.

Fixed-dose combination (FDC) medicines, which are a cocktail of two or more active drugs packed in a single dose has a domestic pharmaceutical market size pegged at around Rs 1.18-1.2 lakh crore, and FDCs reportedly make up nearly 50% of the sales.

To understand the whole design one need understand that even after the threats that are posed by the these FDCs, what is the logic behind using these by pharma companies?

Pharma companies, use FDCs because it is far cheaper and quicker to combine existing active ingredients to make new products than to discover new medicines and manufacture them separately.

Companies find this as a good marketing strategy to create new brand names so that the people are attracted to buy these medicines. They promote every new FDC as a unique and innovative product for purely commercial reasons and support its sales through sophisticated marketing strategies.

The health ministry took this decision after the Drugs Technical Advisory Board recommended that “there is no therapeutic justification” for the ingredients contained in the banned FDC drugs and that these medicines “may involve risk to human beings”.

Health experts have long maintained that many FDC combinations in the market neither boast an advantage over individual drugs nor are safe. Simple logic dictates that chances of adverse drug effects and drug interactions can go up if medicines are combined instead of being taken separately. Apart from the fact that some of the drugs reportedly boast dangerous side-effects, unnecessary use of combination drugs makes the human body resistant to treatment.

Hence, in a bid to stop the irrational use of FDCs, the Union Health Ministry banned the manufacture, sale or distribution of 329 varieties of FDC drugs for human consumption. The move affected over 6,000 medicine brands.

“The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion,” the All India Drug Action Network, a civil society group working on safety and access to medicines and one of the petitioners in the Supreme Court case, said in a statement.

Actually, the health ministry has been gunning for “irrational” and “unsafe” FDCs for over three years now. In March 2016, the government had banned 344 FDCs, adding five more to the list subsequently, following a report submitted by the Prof CK Kokate committee.

But drug makers, including Pfizer, Procter & Gamble, Abbott, Glenmark, Sanofi, Wockhardt, Cipla, Lupin and Dr. Reddy’s, had immediately moved various courts against the decision. The Delhi High Court alone had received over 450 petitions seeking a stay on the ban.

In December 2016, the Delhi High Court quashed the Centre’s decision, noting that it had acted on the advice of a ‘technical committee’, instead of consulting the Drugs Technical Advisory Board (DTAB) or the Drugs Consultative Committee. According to the bench, this violated the provisions of the Drugs and Cosmetics Act.

The health ministry had challenged this ruling in Supreme Court and, in December.r 2017, the latter directed DTAB to decide the fate of these FDCs.

Meanwhile, Asst Drug Controller, Jammu, Surinder Tickoo told that the department has been making every effort to create awareness among the people as well as creating systems of vigilance. He said that since the ban on FDCs has come into effect they have done wide publicity and have been checking at every level.

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