The first nation-wide survey of medicines produced in India has revealed that made-in-India drugs are both safe and effective.

The survey, in which health ministry officials as well as representatives of the pharmaceutical industry and civil society were involved, studied nearly 50,000 samples of drugs collected from across the country to arrive at the conclusion.

The study was undertaken in the wake of concerns that several medications produced in India posed risks to patients.

The study found that only ‘a negligible portion’ of drugs made in the country failed to meet standards. It recorded only 3.5 per cent of drugs that were below standard.

Drugs are categorized as ‘sub-standard’ for failing to meet quality yardsticks in terms of manufacturing procedure, storage or packaging, and are different from fake drugs, which normally seek to imitate genuine drugs in labeling and seek to deceive consumers without keeping to any of the parameters.

However, some sources are skeptical about the findings of the Health Ministry study, especially in the wake of frequent strictures by the US FDA against drugs made in India. Independent studies say that between one-fourth and one-third of drugs made in India are substandard.

The difference, sources say, could be in the approach. While the FDA will categorize drugs as substandard if set manufacturing procedures are not strictly adhered to, in India, only the end product is tested to ascertain standards upkeep.


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