Banned Drugs Receive Interim Relief from Delhi High Court Till March 28

• Central Government has banned more than 300 fixed dose combinations to curb misuse of drugs and prevent drug resistance
• Delhi High Court provides interim relief to pharma companies on banned drugs till March 28
• Banned drugs are exported to African countries

The Ministry of Health and Family Welfare has issued a Gazette notification on March 10^th 2016 according to section 26(A) of Drugs and Cosmetics Act 1940 to ban the manufacture, sale and distribution of over 300 fixed dose combinations in India due to its posing threat on people’s health. The ban on drugs is mainly to curb the misuse of the drugs and prevent drug resistance. A fixed dose combination (FDC) is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form. Combination drugs are easier to use as people take one drug rather than several and can have better compliance.

Since 1961, approval by Central Drug Standard Control Organization (CDSCO) has been made mandatory for sale of fixed dose combination (FDC). Several amendments to the rules, particularly the last one in 2002, had clearly expressed concerns over unapproved FDC formulations. But still, the proportion of unapproved FDC formulations did “not decrease overall” after May 2002.

An expert committee was framed by the Central Government in 2014 to classify the drugs into rational, irrational and those that needed further evaluation. Based on the responses and assessment of the products, the drugs have been banned. The banned list includes analgesics, antibiotics and cough syrups while some of these drugs are also sold over-the-counter (OTC).

Some of the common FDCs banned include very popular drugs such as Pfizer’s Corex syrup, P&G Vicks Action 500 Extra, Piramal’s Saridon, Glenmark’s Ascoril, Abbott’s Phensedyl and Alembic ‘s Glycodin cough syrup.

To view the full list of banned fixed dose combinations as of March 2016, click here.

The Pharma industry has been suddenly caught unaware and they appealed to the Delhi High court on this ruling, that they felt was unfair and unnecessary. The High Court has adjourned the hearing of the pleas of 30 Pharma Companies till March 28. And the temporary relief to the companies will continue till the next scheduled hearing.

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The Delhi High Court had questioned the government on the sudden imposition of ban on combination drugs that have been on the market for the last 20 years. After the ban was announced, various pharmaceutical companies and Indian Pharmaceutical Manufacturer’s Association have threatened to go on strike if the ban on some of the combination drugs is not canceled.

The ban imposed on drugs is likely to cause a huge loss of nearly Rs.1000 crores to the pharma industry. However, the annual loss may go up to Rs.10,000 crores if more drugs are banned. Therefore, many pharmaceutical companies have taken the legal route.

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Fixed dose combination drugs are used worldwide to improve patient compliance, but  because of inconsistent drug laws in the country, hundreds of such medications have entered the market only with the approval of state regulatory authorities, but not central authority.

FDC medication requires license from Drugs Controller General of India (DCGI) for sale and manufacture. But for companies like Unichem laboratories, Geno Pharmaceuticals, the State Government has given the power for marketing, distribution and sale of drugs. Therefore, High Court has sent the notification to the State Governments to take action on them instead of the Drug Controller General of India.

The Pharma companies claim that the decision on sudden ban of drugs was made by the Government without issuing any prior notice. Sanjay Jain, Government lawyer stated that “Commercial interests are not larger than public health”.

The Central Government has also stated that it is necessary to prohibit the manufacture, sale and distribution of these drugs for the benefit of the public.

Many fixed dose combinations are unsafe and even dangerous. Side effects of these drugs mostly go unreported since patients do not return to the doctors for consultation.

The Health Ministry also feels that fixed dose combination antibiotics are causing anti-microbial resistance and the usage could even result in organ-failure. The objective of regulatory authority is to ensure that only safe products should be available in the market. Evidence from research papers and studies have shown that certain FDCs are irrational combinations and may involve human risk, hence safer alternatives that are available should be used.

Export of Banned Drugs

The Drug Control Department also said that the banned drugs are not to be consumed in India, but if the importing country has no objections, then drug controller cannot stop their export. The 344 drugs are now being diverted to African countries or SAARC countries except Pakistan and Afghanistan.

References:

1. http://cdsco.nic.in/writereaddata/SO%20705%28E%29%20TO%201048%28E%29%20DATED%2010-03-2016.pdf

Source-Medindia