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For the last several years, the Indian drug authorities have been facing the twin issues of quality of drugs produced in the country and distribution of counterfeit drugs in the Indian pharmaceutical market. Even though the country has come a long way to adorn the epithet of 'the pharmacy of the world', the Indian pharmaceutical industry’s image was severely tarnished during the last some years as the World Health Organisation held Indian pharma companies accountable for exporting contaminated medicines in the aftermath of deaths of several children in Gambia and Uzbekistan in a couple of years back. The ‘Gambian tragedy’, and some other subsequent similar incidents in other countries and also in India, gave a rude reminder to the Indian drug authorities to maintain the quality of drugs produced in the country. As a quality boost became the need of the hour, the Union Health Ministry introduced the Revised Schedule M, obviously to plug the loopholes in the regulatory system to prevent the repeat of such unpleasant incidents which were a blot in the image of the Indian pharmaceutical industry. Of course, it was a right and timely move to achieve global quality standards in the Indian pharmaceutical industry. Like the quality issue, the menace of counterfeit medicines has also been a major issue, the Indian drug authorities have been facing for a long time now. The front pages of the Indian newspapers have very often been carrying the reports of distribution of counterfeit drugs in the Indian pharmaceutical market. As the menace became so rampant, the Union Health Ministry introduced QR code mandatory on the packaging of top 300 brands of life-saving medicines from August 1, 2023. For this purpose, the Ministry introduced a new Schedule H2 with a list of 300 top brands.
No doubt, the Ministry’s move to introduce QR code was a well considered decision to help trace source and affirm authenticity of medicines while also improving patient health and safety. The Ministry’s move in this regard was in line with the recommendation of the Drugs Technical Advisory Board (DTAB), which had recommended introduction of barcode or QR code on the top 300 brands of medicines available in the Indian market to help track and trace these brands. The QR code, which will prevent the sale of counterfeit drugs, will also verify whether a drug is genuine or counterfeit, and will include information such as the company, manufacturer, expiry date, and brand name, among other things. The QR code was introduced not only to identify misbranded or counterfeit pharmaceutical products but also to help to recall these products if there is a quality issue with the product. Recently, the Ministry has expanded the ambit of Schedule H2 to bring additional categories of drugs under the QR code-based track and trace framework, in a phased manner. Under the latest amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and all anti-cancer drugs have been included under Schedule H2 of the Drugs Rules, 1945. Of course, the Ministry has taken a good decision in expanding the ambit of Schedule H2 as there can be no difference of opinion about the fact that proliferation of fake medicines is an alarming public health crisis.
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