Government has banned more than 300 fixed dose combinations to curb misuse
of drugs and prevent drug resistance
High Court provides interim relief to pharma companies on banned drugs
till March 28
drugs are exported to African countries
The Ministry of Health and Family Welfare
a Gazette notification on March 10th
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
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.
‘Pharmaceutical companies receive interim relief from the ban on fixed dose combination drugs as the Delhi High Court grants stay till March 28.’
Since 1961, approval by Central
Drug Standard Control Organization
has been made mandatory for sale of fixed dose combination (FDC)
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
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.
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
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
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
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.
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.