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Banning of FDC Drugs
Posted on: 26/Apr/2016 4:15:53 PM
Fixed Dose Combinations (FDCs) containing drugs combined together for the first time are treated as New Drugs. These, therefore, require permission from the Drugs Controller General (India) [DCG(I)] before these could be licensed by the State Licensing Authorities (SLAs) for manufacture for sale in the country. Many SLAs had, despite not having the authority to grant licences for new FDCs, continued to grant licences without approval of the DCG(I).
In order to address this issue, 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.
The Department Related Parliamentary Standing Committee (PSC) on Health and Family Welfare had, in its 59th Report, observed that some State Licensing Authorities had issued manufacturing licences for a very large number of FDCs without prior clearance from CDSCO and this had resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety. The Committee had also noted that this could put patients at risk.
The Parliamentary Standing Committee had also 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unauthorized FDCs that pose risk to patients and communities, such as a combination of two antibacterials, need to be withdrawn immediately due to the danger of developing resistance that would affect the entire population. DCG(I) had requested all State/UT Drug Controllers to ask the concerned manufacturers in their States to prove the safety and efficacy of such FDCs as had been licensed by SLAs prior to 01.10.2012 without obtaining the approval of DCG(I) within a period of 18 months, failing which, such FDCs would be considered for being prohibited for manufacture and marketing in the country.
In reply, CDSCO received approximately 6320 applications from manufacturers for proving the safety and efficacy of these FDCs. On scrutiny, it was observed that many FDCs are being manufactured by a number of applicants. With the approval of the Ministry, CDSCO constituted 10 Expert Committees on 03.02.2014 for examining the safety and efficacy of these FDCs. These Committees could, however, examine only about 295 applications.
Subsequent to that the Central Government appointed an Expert Committee to examine the matter. The Committee was also assisted by eminent experts in different therapeutic areas from premier Medical Institutions and hospitals. The Expert Committee, after detailed examination and deliberations recommended that some of these FDCs lacked therapeutic justification; were found to be pharmacokinetically or pharmacodynamically incompatible; had abuse potential; or could lead to antibiotic resistance in the population.
The Expert Committee carried out a comprehensive review of the FDCs keeping in view the contemporary scientific knowledge and expertise. On the basis of the recommendations of the Expert Committee, the Government examined the matter further and requested the Committee to provide specific reasons in respect of each FDC that was found to be irrational. The Committee, accordingly reviewed the matter further and finalized its recommendations.
After careful l consideration of the matter, the Government issued show cause notices to all the manufacturers whose products were found to be irrational and who had submitted their applications to the Central Drugs Standard Control Organization. At the request of the manufacturers, additional time of three months was given to them to respond to the show cause notices.
Thereafter, after due consideration of the report and replies, the Government vide Gazette Notifications S.O. Nos.705(E) to 1048(E) dated 10.03.2016 prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs with immediate effect in public interest as use of such FDCs was likely to involve risk to human beings whereas safer alternatives to these drugs were available. The FDCs that have been held irrational had been licensed by the State Licensing Authorities without approval of the DCG(I). However, in case of a few of these FDCs, approval had also been given by the DCGI.
The Health Minister, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.
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