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Ban On Fixed Dose Combinations PDF
Ban On Fixed Dose Combinations PDF
LARRDIS
LOK SABHA SECRETARIAT, NEW DELHI
REFERENCE NOTE
No.14/RN/Ref./March/2017
1
For the use of Members of Parliament NOT FOR PUBLICATION
Prepared by Smt. Sunanda Das Mohanty, Additional Director (23035036) and Shri Rajkumar Patton,
Junior Library Assistant of Lok Sabha Secretariat under the supervision of Smt. Kalpana Sharma, Joint
Secretary and Dr. P. J. Antony, Director.
The reference material is for personal use of the Members in the discharge of their Parliamentary duties, and is not
for publication. This Service is not to be quoted as the source of information as it is based on the sources indicated
at the end/in the text.
BAN ON FIXED DOSE COMBINATION (FDC) DRUGS
The Government of India banned 344 Fixed Dose Combination (FDC) drugs
on 10 March 20161 citing health reasons and lack of therapeutic justification. FDCs
are drugs with two or more active pharmaceutical ingredients combined in a fixed
dose to form a single drug2. For over 30 years pharmaceutical companies have
been selling these FDCs with scant regard for their efficacy, safety or rationality
for use.
Process for marketing a drug- Any new drug requires prior approval from the
Drugs Controller General (India) [DCGI] before these are licensed by the State
Licensing Authorities (SLAs) for manufacture and sale in the country. As FDCs
are combinations of certain drugs that are combined together for the first time,
these are treated as „New Drugs‟. Many SLAs granted licences to some new FDCs
without the approval of the DCG (I) on assessment of safety, efficacy and
rationality. This led to availability of a number of FDCs in the Indian market
without any knowledge about their safety and efficacy on Indian population.
1
Vide Gazette Notifications S.O. Nos. 705(E) to 1048(E).
2
For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent or reduce
fever). Cough syrups Phensedyl and Corex, the widely advertised Vicks Action 500, antibiotic combination Zimnic AZ are some
of the popular FDCs, which involve commonly used medications such as paracetamol, aceclofenac and nimesulide.
3
CDSCO-(Central Drugs Standard Control Organization )- is the Central Drug Authority for discharging functions
assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four
sub-zonal offices, 13 port offices and seven laboratories under its control.
2
availability of many FDCs in the market which had not been tested for efficacy
and safety. The Committee had also noted that this could put patients at risk. It
pointed out that 'Such irregular approvals spare drug producers the cost and
efforts but put Indian patients at risk. On an average DCGI is approving one drug
every month without trials. This cannot be in public interest by any stretch of
imagination.'
The Parliamentary Standing Committee expressed the view that those
unauthorized FDCs that pose risk to patients and communities, such as a
combination of two antibacterials, need to be withdrawn immediately due to the
danger of developing resistance that would affect the entire population.
(ANNEXURE II).
Government’s Action
The Government accepted many of the recommendations of the
Parliamentary Committee and the Ministry of Health and Family Welfare issued
statutory directions to the State Governments to instruct their respective drugs
licensing authorities to refrain from granting such licenses. However, the practice
was still not discontinued by some of the SLAs.
Further, in a letter dated 15 January 2013, the DCGI asked manufacturers to
produce safety and efficacy data of their FDC products from the central
government or stand the risk of their licences being cancelled. This direction was
given for all products approved after 29 September 1988 and before 1 October
2012. Most manufacturers complied only after a lot of hesitation and procedural
wrangling, and after several extensions of deadlines and reminders. An 18-month
window ending on 14 July 2014 was given for applications from manufacturers
justifying the safety, efficacy and rationality of their products.
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CDSCO also set up 10 professional committees in February 2014 to analyze
the rationality as well as safety and efficacy of the FDCs. After careful
consideration of the recommendations of the Committee and of the entire matter,
the Government issued show cause notices to the manufacturers whose products
were found to be irrational. At the request of the manufacturers, additional time of
three months was also given to them to respond to the show cause notice.
Ultimately, after due consideration of the report and replies, the Government of
India banned 344 FDCs on10 March 2016.
Following the ban, the drug companies continue to insist on marketing
grossly irrational, unsafe and ineffective products. Pharmaceutical companies have
teamed up to mount an intense battle with claims that the future of the industry and
“Make in India” are threatened. They are doing everything in their power to
prevent the government from acting in the public‟s interest. In a major relief to
them, the Delhi High Court quashed the Government Ban in December 2016. The
Centre has now moved the Supreme Court on 30 January 2017 seeking to enforce
the ban once again. It is hoped that the Apex Court will see this as a matter
concerning life and death and will not allow any legal “wizardry” by
pharmaceutical company counsels. That will be the beginning of the long overdue
clean-up of the pharma industry in India.
Conclusion
As the matter is now before the Supreme Court, it is hoped that it will take
into account the serious public health implications of the sale of certain drugs and
allow regulatory intervention banning uncertified combination drugs.
4
SOURCES CONSULTED
Complete list of 344 drugs banned by the Ministry of Health Family welfare
A gazette notification by Ministry of Health and Family Welfare has banned 344
medicines of fixed drug combinations. The Health Ministry banned 344 fixed drug
combinations through a gazette notification. The ban, which comes into effect
immediately, follows recommendations of an expert committee formed to examine the
efficacy of these drug combinations.
Here is the complete list of all drug combinations banned by the ministry: