Home Dehradun Drug manufacturers claim samples failed due to technical issues, not counterfeiting

Drug manufacturers claim samples failed due to technical issues, not counterfeiting

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Garhwal Post Bureau

Dehradun, 2 Jul: The Drug Manufacturers’ Association today strongly asserted that medicines manufactured in Uttarakhand are of assured quality, with Non-Standard Quality (NSQ) drug failures arising from technical discrepancies rather than from counterfeiting. During a press conference held today at the Uttaranchal Press Club, Association President Pramod Kalani emphasised that Uttarakhand is rapidly developing into a major pharmaceutical hub, with a growing number of companies exporting medicines globally. He alleged that certain external elements are attempting to derail the state’s pharmaceutical progress by circulating counterfeit medicines under the guise of local firms and urged strict punitive action against such operations.

Kalani claimed that there is a clear and essential difference between counterfeit medicines and NSQ drugs. According to him, counterfeit drugs are those that deliberately misrepresent composition, identity, or source, often made with inferior materials or mislabelling, whereas NSQ drugs result from unintentional technical anomalies during production or storage. He further claimed that licensed manufacturers do not engage in the production of fake drugs and warned that branding NSQ drugs as counterfeit, especially in media reportage, is misleading and damaging to a company’s credibility.

Association member PK Bansal asserted that NSQ designations typically arise from minor flaws such as deviations in pH levels, delays in disintegration or dissolution, and occasional labelling errors, none of which pose any harm to patients. General Secretary Sanjay Sikaria added that even in the recent instance where 27 drug samples were reported to have failed tests, the shortcomings were minor and merely technical in nature. He shared that the manufacturers are entitled to a 28-day window to appeal for re-analysis at an upper-tier facility, primarily the Central Laboratory (CDL) in Kolkata. Only after a sample fails at that level can a drug be definitively termed substandard or counterfeit.

Association member Ramesh Jain mentioned the influence of climate on drug quality. He explained that varying climates, such as those in Kashmir, coastal regions, or the North-East, can affect drug stability if proper storage norms are not maintained. Exposure to direct sunlight or improper ambient conditions can degrade medicines, which is why they must be kept in cool and dark environments, a practice not uniformly followed across chemist outlets.

Kalani made a direct appeal to the media, urging them to refrain from prematurely labelling NSQ drugs as counterfeit based on preliminary reports from the Central Drugs Standard Control Organisation (CDSCO). He said such misrepresentation damages brand equity and undermines public trust. He urged that only the final reports from CDL, Kolkata, should be considered before drawing conclusions.

Reinforcing Uttarakhand’s stature as a burgeoning pharmaceutical base, Kalani highlighted that the state now hosts 285 pharmaceutical companies, contributing approximately 20 per cent to India’s total drug production. He credited the state government’s proactive approach and the recent Global Investors Summit for catalysing investment and employment opportunities in the sector.

The press conference was also attended by several key members of the pharmaceutical fraternity, including General Secretary Sanjay Sikaria, Kuldeep Singh, RC Jain, Nikhil Goel, and IPS Chawla.