Govt to consider new drugs bill to regulate imports and manufacturing

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Lawmakers will consider a new drugs Bill next week on rules for importing, manufacturing and selling medicines, according to a parliamentary notice on Thursday, as the country seeks to draw lessons from a deadly cough syrup scandal.

India’s “pharmacy of the world” image has suffered some damage after cough syrups made there were linked to the death of at least 89 children in Gambia and Uzbekistan last year.

The Bill is aimed at ensuring “quality, safety, efficacy, performance and clinical trial of new drugs ... with the objective of highest possible regulatory standards and a transparent regulatory regime,” the notice said.

It was not immediately clear what the changes were in the new Drugs, Medical Devices and Cosmetics Bill, 2023, which will replace an earlier drugs law if passed by the parliament when it reconvenes after a break on July 20.

India’s $41 billion pharmaceutical industry is one the largest in the world and has for years helped provide cheaper alternatives to Western products, especially to poor and developing nations.

But the recent cough syrup-related deaths and at least one other instance of an India-made eye drop being linked to three deaths in the United States, has cast a shadow on the industry's image.

India has made tests mandatory for cough syrup exports since last month. Companies that manufactured the syrups linked to deaths in Gambia and Uzbekistan have denied any wrongdoing.