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CDSCO identifies 300 top brands for ‘trace and track’ mechanism, to meet firms on June 25 to discuss implementation

Arun Sreenivasan, New Delhi
Tuesday, June 19, 2018, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organisation (CDSCO) has taken another step forward in its efforts to introduce an effective “trace and track” mechanism to weed out counterfeit drugs from the Indian market. The national drug regulatory body has identified the top 300 brands, which would be included in the initiative, on the basis of moving annual total (MAT) data and will hold a meeting with manufacturers’ representatives on June 25 to discuss modalities for implementing the initiative.   

Cleared by the Drugs Technical Advisory Board (DTAB) 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. However, the initiative will be implemented on a voluntary basis, according to the minutes of the DTAB meeting.

The CDSCO measure assumes significance as, according to a recent World Health Organisation (WHO) report, an estimated one in 10 medical products circulating in low- and middle-income countries like India is either substandard or falsified. According to the UN agency, these medicines not only fail to treat or prevent diseases but can also cause serious illness or even death. Industry body Assocham estimates that one in five drugs is fake and the industry is growing at 25 per cent every year.

The country’s policy think-tank Niti Ayog is also concerned over the problem and has recently proposed a plan to put the entire drugs inventory made and consumed in the country on blockchain to check the menace. Blockchain 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.

For making the list, the CDSCO has banked on data obtained from AIOCD AWACS. The list of manufacturers includes Abbot India with 13 brands, Cipla Limited with 17, Sun Pharma with 22 brands and Pfizer Limited with 15 products.

 
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Ajay Bapat Jun 19, 2018 4:01 PM
will this be applicable only to top 300 brands ? When we say BRAND will it cover all the dosage forms ( tablets or drops with same brand name ) ? There has to be clarity what is exempted from list like mono cartons ( put code on carton and exempt label )
 
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