Last month, the Lok Sabha passed a Bill that was aimed at improving the ease of doing business in India. This Jan Vishwas Bill, passed by the Rajya Sabha, this month brought in amendments to 42 different laws, including amendments to two sections of The Drugs and Cosmetics Act, 1940.

These drug law changes have sparked a controversy: health activists have said that it essentially decriminalises the manufacture of drugs that are not of standard quality, allowing manufacturers to get away with a fine, with no imprisonment.

The quality of drugs in India, has already been under scrutiny, with the recent deaths of dozens of children in at least two countries, Gambia and Uzbekistan, being linked to contaminated cough syrups manufactured in India. But while such cases of adulterated drugs can attract penal provisions, the bigger problem of substandard drugs that may not work effectively on a patient, potentially making the patient worse, are not dealt with stringently. This is a huge problem, say experts as the Indian pharmaceutical industry, estimated to be worth about USD 41 billion, is one of the largest in the world and provides drugs to a number of developing countries.

How will this recent amendment affect drug laws and pharmacies in India? How do drugs that are not of standard quality affect the human body? What is the problem with the drug regulatory mechanism in our country?

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