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India needs coordination & cooperation of SLAs, CDSCO & industry to eradicate spurious drug menace: Dr Jagashetty
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Nandita Vijayasimha, Bengaluru
March 19 , 2025
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India needs coordination and cooperation of SLAs (state licensing authorities), CDSCO and pharma manufacturers to eradicate spurious drug menace. It is also of paramount importance to strengthen the country’s regulatory system, stated Dr BR Jagashetty, special resource officer, Karnataka FDA, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka State Drugs Controller.
The need of the hour is regular inspections, audits, and cross-verification between the authorities at both the state and central levels which are crucial to address the issue of spurious drugs in India, he added.
Both SLAs and CDSCO should share data on reported counterfeit drugs. In fact, the government needs to mandate track & trace for each batch of the product up to the retail point which may help in finding the counterfeit or spurious drugs to some extent. The same was suggested in 2011 itself by a committee headed by Dr H G Koshia, Commissioner FDA, Gujarat, Dr Jagashetty told Pharmabiz.
The 2012 direction issued under Sec 33P by the government of India to all SLAs restricting to grant licenses only in generic names may be withdrawn. Now it should allow all SLAs to grant licenses in brand name with suitable increased fee. Instead of Rs. 300 as prescribed under drug rules, this will need to be enhanced suitably for each additional product with or without brand name. In fact, there was a draft notification to enhance fee which is pending for final notification, he said.
In order to monitor LASA (look-alike sound-alike) drugs, a suitable mechanism has to be evolved by CDSCO in coordination with SLAs. Stringent regulation needs to be in place while granting permission for propaganda- cum-distribution purpose products, said Dr Jagashetty.
Specifically, SLAs need to have stronger monitoring processes to ensure that only manufacturers with valid licenses are allowed to operate. Pharmaceutical manufacturers, in turn, must adhere to strict guidelines regarding the quality of raw materials, production processes, and distribution channels as per latest Schedule-M and also they should inform the regulators on any doubtful movement of such products in the market, he stated.
Manufacturers, together with regulatory authorities, can conduct awareness programs to educate healthcare providers, pharmacists, and the general public about the dangers of spurious drugs and the mode of identifying them, said Dr Jagashetty.
The adoption of technologies like AI (artificial intelligence), blockchain for drug traceability or QR codes on packaging could improve transparency in the supply chain. CDSCO and SLAs need to ensure such technologies are widely implemented, allowing for better tracking and verification. Cooperation between SLAs and CDSCO would make it easier to identify the source of spurious drugs and to bring the offenders to the book of law, he noted.
India also needs to promote the Whistle-blower scheme to encourage pharma manufacturers, distributors, retailers or individuals to report cases of spurious drugs. Here it needs to be ensured that their protection is through proper whistle-blower policies in place both at state and central level. No doubt the county needs to be efficient in identifying and eradicating spurious drug production and distribution, to ultimately safeguarding public health, said Dr Jagashetty.
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