Union Minister of Health and Family Welfare Mansukh Mandaviya on Tuesday said that after risk-based inspection and audit of manufacturing plants, drug regulators have taken action against 105 pharmaceutical companies. The action by regulators comes following the deaths of dozens of children overseas linked to Indian-made cough syrups.
Mandaviya said that after 137 firms were inspected, production has been stopped at 31 companies and the product licenses of 50 firms have been cancelled. 73 firms have been issued show cause notices and 21 firms have been issued warning letters.
“There shall be no compromise with the quality of drugs manufactured in India”, Mandaviya stated at a meeting with pharma representatives from the medium, small, and micro enterprises (MSME) sector. He added that special squads have been formed to inspect drug-making firms.
Mandaviya emphasised the importance of self-regulation in the firms involved in drug manufacturing in India. “It is important for MSME pharma cos to be alert to the quality of drugs and expeditiously move towards good manufacturing processes (GMP) through self-regulation,” the minister said.
Mandaviya also said the centre plans to make Schedule M mandatory for drug manufacturing units in the country in a phased manner. Schedule M outlines the GMP that these units must follow. “This will help in quality assurance and also reduce compliance burden”, the Union Minister said.
At the meeting, Mandaviya stated that the global position of India in the pharmaceutical sector is due to the quality of its products. He said that all possible steps must be taken to ensure that this position is strengthened in terms of value and quality.