Track and Trace mechanism for Pharmaceutical Products

Since five years, the reforms are being initiated by CDSCO in the drugs regulatory system

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Medicine Tablets
Picture: Unsolash

Expressing its concern on the rising incidences of spurious and adulterated drugs in India, the Department related Parliamentary Standing Committee on Commerce has recommended to the government to roll out a track and trace mechanism at the earliest for the detection of authenticity and genuineness of medicines and medical devices from manufacturers to end users in supply chain.

The surge in spurious drugs in the country is not only a potential threat to the lives of its citizens but also dents its image as being one of the largest suppliers of drugs and pharmaceuticals in the world, stated the committee in its report presented to Rajya Sabha and Lok Sabha on July 23, 2021.

There has been a rise in the number of drug samples declared spurious or adulterated over the last four years. A total of 74586 drug samples were tested in 2015-16. Of them, 3703 drug samples were declared not of standard quality which is 4.96 per cent of the total drug samples while 234 drug samples were declared spurious or adulterated which is 0.31 per cent of the total drug samples.

In 2016-17 about 76721 drug samples were tested. Of them, 2780 drug samples (3.6 per cent) were declared NSQ and 123 drug samples (10.16 per cent) were declared spurious or adulterated.

In 2017-18 around 82599 drug samples were tested. Of them, 2783 drug samples (3.36 per cent) were declared NSQ while 236 drug samples (10.28) were declared spurious or adulterated.

In 2018-19 over 76101 drug samples were tested. Of them, 2549 drug samples (3.35 per cent) were declared NSQ while 205 drug samples (10.27 per cent) were found spurious or adulterated.

Laboratory
Picture: Pixabay

The committee raised its concern on the rise in manufacturing of spurious and adulterated drugs in the country.

In this regard, the Department of Pharmaceuticals (DoP) informed that various measures are being undertaken by the Central Drugs Standard Control Organisation (CDSCO) to address the issue of spurious drugs and ensure the quality of drugs in the country.

The CDSCO is responsible for approval of drugs, conduct of clinical trials and in laying down the standards of drugs in the country.

Since five years, the reforms are being initiated by CDSCO in the drugs regulatory system which include strengthening of testing capacities of Central Drugs Testing Laboratories under CDSCO and amendments in the Drugs and Cosmetics Rules, 1945 to bring in stricter rules pertaining to manufacturing of pharmaceuticals such as submission of bioequivalence study when applying for license of oral dosage form of certain drugs, joint inspection of manufacturing establishment by drugs inspectors of both central and state government, etc.

Besides the committee’s recommendations, the implementation of bar coding/QR coding as part of trace and track mechanism for pharmaceutical products has been under discussion for quite some time now.

The Drugs Technical Advisory Board (DTAB), the highest decision-making body under the Union health ministry on technical matters, deliberated the issue of bar coding or QR coding on packaging of drugs in its meeting a couple of months back and deferred for examining it separately in its next meeting.

Earlier, the DTAB in its 79th meeting held on May 16, 2018 agreed for introduction of a trace and track mechanism for major 300 pharmaceutical brands on a voluntary basis. The Board informed that an order may be issued by Drugs Controller General of India (DCGI) to all the concerned to this effect.

Subsequently, the Union Health Ministry has published draft notification vide GSR. 567 (E) on August 8, 2019 mandating QR code for active pharmaceutical ingredients (APIs) only based on the recommendations of 82nd DTAB meeting. A number of objections have been received from the industry, which are being examined.

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