Tribunal to address drug makers’ woes

Tribune News Service

Solan, August 10

The Union Government will set up a Drug Tribunal Board (DTB) to address the issues of manufacturers pertaining to the implementation of the Drugs and Cosmetics Act.

Union Minister for Health and Family Welfare, and Chemicals and Fertilisers Mansukh Mandaviya took a decision to this effect in a meeting convened by the National Pharmaceutical Pricing Authority recently to ponder trade margin rationalisation, says Dr Rajesh Gupta, who heads the All India Pharma Committee of Laghu Udyog Bharti (LUB). The minister directed the officials concerned to make preparations for the constitution of board, Gupta adds.

Representatives of various pharmaceutical manufacturing associations, including the LUB, the Small and Medium Pharma Manufacturers Association and the Indian Federation of Pharma Generics, say they are facing several cases due to faulty interpretation of the law on “spurious” drugs.

Manish Thakur, general secretary, Himachal Drug Manufacturers Association, says, “At present, there are ambiguities in the implementation of the DCA as it doesn’t define substandard and spurious drugs appropriately. Issues such as faulty storage conditions often deteriorates drug quality and a manufacturer has to face cases when such drugs are declared spurious.”

“The constitution of the DTB will provide a platform to the manufacturers where they can plead their stand before technical experts before being prosecuted for spurious drug manufacturing,” he adds.

Manufacturers say that they also face court cases in other states which causes a lot of inconvenience. There was no platform for them to air their grievances before technical experts, who could differentiate between manufacturers adopting malpractices and others who had no intention of compromising with the quality of drugs.

The Central Drugs Standard Control Organisation notifies drug alerts every month where drug samples lifted from various states are tested in government labs and those found substandard and spurious are notified. Batches of such drugs are supposed to be withdrawn from the market and the state drug authorities are supposed to initiate prosecution against spurious drug manufacturers.

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