Maintaining Standard of Made-in-India Drugs of ‘Paramount Importance’, DCGI Tells States & UTs

Maintaining the standard of made-in-India medicines is of ‘paramount importance’, the country’s apex drug regulator has told states and Union Territories amid fixing quality issues of the Indian pharmaceutical industry.

The move is driven by a “public grievance” which suggests the regulator improve the standards of raw materials — called Active Pharmaceutical Ingredients (API) — used in manufacturing the medicines.

“This is with reference to the public grievance received in this office regarding improving the standards of API which are sold in the Indian market,” said the letter sent by DCGI Rajeev Singh Raghuvanshi.

In medicine, API produces the intended effects to cure the disease. For instance, Paracetamol is the API for Crocin and it is the API Paracetamol that gives relief from body ache and fever. Poor quality of APIs will make the consumption of medicines futile.

Raghuvanshi, in the letter dated April 21, reminded the state regulators and officials that “it is of paramount importance that the drugs are required to be manufactured in compliance with the standards prescribed in the Second Schedule of Drugs & Cosmetics Act 1940 and the Rules made thereunder…” He concluded the letter requesting “compliance” with the set standards.

Meanwhile, the Ministry of Health and Family Welfare is already conducting massive nation-wide audits and raids at several drug manufacturing units to fix the gaps in good manufacturing practices.

The latest moves are driven by multiple allegations levelled by importers of Indian medicines, including Uzbekistan, Gambia and the United States. Since October last year, India has been facing allegations of exporting spurious quality drugs, raising concerns of denting the decades-old reputation of “pharmacy to the world”.

Letter to states & UTs

The letter, which is also sent to drug regulators of all states and Union Territories along with all zonal and sub-zonal offices of CDSCO, emphasises that the officials across states must follow the standards prescribed in the Indian Pharmacopoeia — a book which is created to set standards of drugs in the country.

He also added that the inspectors must remember that for drugs not included in the Indian pharmacopoeia, global standards must be followed.

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