CDSCO sets up panel to weigh ‘trace and track’ mechanism for top 300 drug brands, report expected in 4 months

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The Central Drugs Standard Control Organisation (CDSCO) will constitute an expert sub-committee to weigh the pros and cons of a ‘trace and track’ mechanism proposed for the top 300 drug brands in the country, it is learnt. The fate of the initiative, aimed at weeding out counterfeits from the market, now depends on the report of this panel which includes representatives of drug manufacturers.

The decision to form an expert sub-committee was taken at a meeting between regulators and representatives of drug manufacturers on June 25. The proposed initiative allows consumers to check the genuineness of a medication they have bought with just a text message.

“The sub-committee includes an office bearer and a technical expert each from all drug manufacturers’ associations. The panel will submit its report in four months which will be a deciding factor whether it is practically possible to introduce this system or not,” Federation of Pharma Entrepreneurs (FOPE) president BR Sikri told Pharmabiz.

The industry had expressed concerns over the financial strength of small and medium drug manufacturers to adopt the mechanism if it was extended to all brands. However, the regulator allayed their fears saying the mechanism would be for top 300 brands only.

The CDSCO has also made it clear that the proposal is for an authentication system, which is cheaper than a ‘trace and track’ mechanism. “We’re also assured by the regulator that the initiative won’t be made mandatory and will be implemented on a voluntary basis,” Sikri added.

Cleared by the Drugs Technical Advisory Board during a meeting in May, the plan is to print a 14-digit number on the labels of the top 300 pharmaceutical brands along with a mobile number of the manufacturer. Since the numbers will be unique to each strip and bottle sold in the market, a consumer can easily check the genuineness and quality of a drug by sending a text message to the given number and get details of the manufacturer, batch number, expiry data etc.

Counterfeit or spurious drugs are a widespread problem in India. Expressing concern over the issue, Niti Ayog, the country’s policy think-tank, has recently proposed a plan to put the entire drugs inventory made and consumed in the country on blockchain. The technology stops the entry of fake drugs into the supply chain, mainly the part between the manufacturer and consumer. It uses a highly scalable transparent protocol to assign every manufactured product an asset. The assets are then added to the blockchain and assigned a unique identification number, commonly referred to as hash. The technology then verifies the hashes to find out whether or not the product in question is counterfeit or legitimate.

The national drug regulatory body identified the top 300 brands on the basis of moving annual total data obtained from AIOCD AWACS. The list of manufacturers include Abbot India with 13 brands, Cipla Limited with 17, Sun Pharma with 22 brands and Pfizer Limited with 15 products.

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