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The drug control authorities in the states and Union Territories (UTs) have unanimously agreed to comply with the Central drug regulator's direction that no license will be issued to the drug formulations falling under the purview of new drugs without approval from the Central Licensing Authority (CLA).
The development is latest to the lingering issue of State Licensing Authorities (SLAs) giving consent to manufacture and sale of drugs which fall under the purview of new drugs as defined in Rule 2(w)(iv) of NDCT Rules, 2019, from the CLA.
The issue was discussed in a Drugs Consultative Committee (DCC) meeting held in June, where the Committee observed that as per the rules, the SLAs must check the approval, in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug under the NDCT Rules.
It also observed that time and again it has been brought to the knowledge of CDSCO that manufacturing permission for such new drugs are issued by State Licensing Authorities without necessary permission from the CLA. The CLA has issued various directions as well as letters in this regard.
"After detailed deliberation, all the members unanimously agreed for compliance of necessary permission from CLA before granting any licence to the manufacturers," said the minutes of the DCC meeting.
DCC has members from the drug licensing authorities of all the States and UTs in the country, apart from the representatives from the CDSCO, and directors of laboratories of CDSCO, among others.
The central drug regulator has been raising concerns since January, 2013, regarding the grant of manufacturing licenses for sale of the FDC drugs that fall under the definition of a new drug in the country without due approval from DCGI.
It has also initiated action against hundreds of fixed dose combinations (FDCs), which were identified as irrational and have not undergone the approval procedure of the CDSCO based on the rules and regulations, as irrational combinations.
Some of these decisions have resulted in a series of litigations initiated by the companies against the drug regulatory organisation in various Courts across the country.
As reported earlier, in a recent development in April, this year, the Drugs Controller General of India (DCGI) has sought the drug controllers of states and Union Territories (UTs) to act upon a list of 35 FDCs, which fall under the definition of new drug, which has been licensed by the State drug regulators without prior evaluation of safety and efficacy as per the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019.
He also asked the state and UT drug controllers to review their approval process for such FDCs for strict adherence. The matter may be treated as urgent and serious, added the official.
The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation. Upon issuance of show cause notices to the manufacturers, they have stated that these licenses were granted by the respective SLAs and the companies have not violated any Rules.
"This has resulted in a lack of uniform enforcement of the provision of the NDCG Rules 2019 under the Drugs & Cosmetics Act, 1940 across the country," said DCGI Dr Rajeev Singh Raghuvanshi in a letter to all State and UT drug controllers in April.
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