The Union government on Tuesday announced that it is cancelling the licenses of 18 pharmaceutical firms due to poor quality medicines they produce while another 26 have been served show-cause notices as a consequence of a country-wide drive against such below-standard drugs produced by a section of the companies.
In the past fortnight, the Drugs Controller General of India inspected 76 pharma industries to check whether they were producing spurious / not-of-standard-quality / adulterated medicines, besides examining if the units follow good manufacturing practice norms.
“The licenses of 18 firms have been cancelled and they have been ordered to stop production,” sources in the Union Health Ministry said without disclosing the names of the companies.
In addition, 26 companies received show-cause notices and product permissions have been cancelled for three firms.
The 76 units that were inspected in the first phase, are among 209 firms in 20 states identified by the government for checks. The majority of these companies are in Himachal Pradesh (70) followed by Uttarakhand (45) and Madhya Pradesh (23).
The action comes after three international alerts on the quality of made-in-India medicines in the last six months following which Union Health and Pharmaceutical Minister Mansukh Mandaviya asked the regulatory agencies from the central and state administrations to work together for plugging the regulatory loopholes to ensure top quality for Indian medicines.
The alerts from the WHO were on the tragic episodes in Gambia in October 2022 and Uzbekistan in December 2022 linking specific Indian-made cough syrups to child deaths in the two countries whereas the US authorities alerted last month on the quality of certain eye drop brands from India to link them to bacterial infections in people.
Last week the ministry informed the Lok Sabha that it received alerts from the WHO on two more firms – Maharashtra-based Galentic Pharmaceuticals for the tetracycline that it produced and Celon Laboratories, Telangana for the methotrexate it manufactured.