Editorial: Standardise drug regulation

The health ministry's latest proposal to formulate common standards for drug regulators at the Centre and in the States is a welcome development

Hyderabad: For India’s export-oriented pharmaceutical industry, it is the global perception that matters most. The recent tragedies in Gambia and Uzbekistan, where the death of nearly 90 children was linked to adulterated cough syrup manufactured by Indian pharma companies, have seriously damaged the country’s reputation as a global pharma hub. Against this backdrop, the health ministry’s latest proposal to formulate common standards for drug regulators at the Centre and in the States is a welcome development. The idea is to maintain a central database to better regulate the manufacturing, sale and distribution of drugs. Such a move has the potential to transform the drug regulatory system by erasing the overlapping patchwork of monitoring authorities, and bringing it up to global standards. However, the implementation needs a careful and sensitive approach since health is a State subject. The success of the initiative requires stakeholders’ participation — similar to the one that went into the implementation of the Goods and Services Tax . The GST rollout preceded years of meticulous groundwork. The model has proved to be a win-win for all and a reflection of the robustness of the federal set-up. A similar spirit of cooperation can be replicated in making the drug regulatory system more effective. At present, there are 38 drug regulators — one for each State and union Territory, in addition to the national regulator, Central Drug Standard Control Organisation (CDSCO). Each of them has its own network of laboratories, inspectors and jurisdiction. As a result, they operate in silos, making the whole system opaque.

Currently, only a handful of drug-testing laboratories make their results available in a consolidated database and the States maintain their inspection and quality control records in different formats. Under the present set-up, if violations are found in the functioning of a drug company in a State, such information will not be shared with the drug regulators of other States or with the CDSCO. This renders the regulatory mechanism ineffective. For a country whose pharmaceutical industry has a larger global profile, this is not a desirable situation. There is a need for a common set of standards and regulations. India does not have a consolidated public database that records the transgressions of each company licensed under the Drugs And Cosmetics Act. In the last six months, there have been at least three cases of deaths reported globally that are linked to drugs exported from India. Last month, a Chennai-based pharmaceutical company, Global Pharma Healthcare Private Limited, recalled a batch of eye drops from the US market after the US FDA said they were contaminated with a drug-resistant bacteria linked to permanent vision loss and had resulted in one death from a bloodstream infection. The death of children in Gambia and Uzbekistan due to adulterated cough syrup supplied by Indian companies came as a major embarrassment to the country.

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