‘Useless’ combination drugs banned

If some medicines are found to be “harmful” or even useless to consumers, the government or the apex drug regulator can ban them. Logically, such drugs should be banned before they hit the market and their samples make rounds of doctors’ chambers.  In fact, drugs can’t be sold in the market for public consumption without prior regulatory approval. Therefore, it is difficult to understand the government’s sudden ban on 344 drugs, last week, sending industry and trade in a tizzy and consumers of these medicines totally shocked and confused. Most of these medicines have been on the market for years, if not for decades, and are regularly prescribed by doctors. What did the government do all this time? The drug industry and trade are understandably up against the government order. They say the ban could cost them close to Rs. 4,000 crore. No one knows what it has already cost helpless consumers, who may be holding stocks of many of these drugs purchased from chemists over-the-counter or under prescriptions from medical practitioners.

To be honest, this is not the first time that “irrational” combination drugs have come under the official scanner.  The writings have been on the wall for several years. But, knowing fully well about how India’s government machinery operates, industry refused to take it seriously and expanded the range of combination drugs ever since the Central government’s Drug Price Control Order (DPCO) started to expand its ambit to fix the prices of more and more essential medicines. Combination drugs were an industry invention mostly to help drug producers bypass the government’s price control regime. However, this is not to suggest that all combination drugs are the bi-product of DPCO and all fixed dose combination (FDC) drugs are without “therapeutic justification” and “involve risk to human beings”.

Last year, the government reviewed some 6,200 combination drugs, of which some 15-20 percent were considered absolutely “irrational”. Way back in 2007, state governments were asked to withdraw 294 combinations that were in the market without even the Central government approval. Drug companies and industry associations immediately used legal means to push back the government’s order. For reasons best known to the Congress-led UPA regime, the then government did not pursue the matter that had further emboldened the powerful pharmaceutical industry to experiment with this novel pricing and marketing route. This time too, industry and trade bodies have quickly sought a legal remedy to the government’s ban order and received short-term interim relief. Some of the companies have engaged expensive high-profile lawyers, including some former Congress ministers, to fight for them. The industry has also garnered the support of a section of practicing doctors, who ferry medicines through prescriptions, to contest the government’s claims about the utility and efficacy of these banned FDC drugs. Interestingly, a report by US healthcare provider IMS Health said almost half the drugs sold in India in 2014 were FDC, promoting the country as a world leader in combination drugs.

A recent study published in the journal of Public Library of Science revealed a rather shocking information claiming that over 70 percent of non-steroidal anti-inflammatory drug (NSAID) combinations, which are used as painkillers, were marketed in India without any Central government approval. There is not much reliable information in the form of data availability on multi-drug interaction in a single dose on patients or side effects of combination drugs, including resistance aspect. Manufacturers often take advantage of the lack of coordination between the Central and state regulators to market “unapproved” FDCs. The existence of combination drugs in India is highly common in almost all therapeutic areas and medicines such as cough syrups having codeine combinations, analgesics, antibiotics and NSAID. Last week’s banned list of 344 combination drugs covers 27 anti-diabetic drug metformin combinations, 16 anti-inflammatory nimesulide, half a dozen codeine combination cough syrups and some 18 diclofenac among others.

Although a number of high selling combination drugs manufacturers, several of them being leading multinational corporations from the US and Europe, have sought the legal remedy to continue with their business, it may also be important to note that many of them have stated that they would stop manufacturing and marketing these drugs with immediate effect. The stock exchange listed drug companies have already made “regulatory filing” with Bombay Stock Exchange about their product ban and, in the process, lost sizeable market capitalisation depending on the possible loss of turnover and profitability on such account. The industry is aware that the government has strictly gone by the recommendations of the expert committee on the subject. The committee is believed to have gone through a detailed, scientific, and transparent process of decoding the combinations of FDCs before recommending the ban of those FDCs which were “irrational combinations” and “unsafe for health”. Incidentally, few of those combination drugs actually had any approval from the Drugs Controller General of India (DCGI). These drugs are sold across the country on the basis of approval from one or other state government. The Drugs and Cosmetics (amendment) Act-2009 requires that every drug manufacturing company has to take approval from DCGI.

However, the mystery behind the government’s belated action to ban those combination drugs after their being in the market for years or decades remains unresolved. No one can say for certain how the judiciary will ultimately react to the government action though the judiciary is not expected to act as the nation’s drug regulator. The government must produce authentic national and international data on the utility and efficacy of those banned combination drugs in support of its action. After all, the drug industry and its products are regulated all over the world. It can’t be different in India, which is projected to emerge as the world’s third largest pharmaceuticals producer within the next four years.