Himachal: 13 companies ordered to stop drug production

Himachal Pradesh: To ensure the manufacture of quality medicines, the state and central drug regulatory authorities have taken action against 13 pharmaceutical units located in various industrial clusters of Himachal for non-adherence to quality parameters. These firms, located in Baddi, Nalagarh, Solan and Sansarpur Terrace, have been directed to shut down manufacturing operations or their licences will be suspended. While the licences of seven firms may be suspended and their manufacturing operations completely stopped, six others are facing partial suspension of drug production under specific sections after deficiencies were found in their manufacturing protocols. Officials of the state drug authorities and Central Drugs Standard Control Organisation (CDSCO) had conducted risk-based inspections of 42 firms in various industrial clusters since May this year. The inspections found several deficiencies, including lack of regular maintenance of equipment. State Drug Controller Manish Kapoor said the state and central regulatory authorities are conducting risk-based inspections in pharmaceutical units. He said, “Firms whose names frequently appear in the monthly drug alert and their products are found to be not of standard quality are subjected to special inspection. Actions like partial or complete shutdown of production are taken against them depending on the severity of the deficiencies.” Since there are 650 drug units operating in the state, the number of samples of products not meeting quality standards in the monthly alert is usually high. In the alert issued in October, 25 drug samples, including 11 injections, were found not conforming to quality standards. After the firm takes action as per the inspection, it is re-inspected and the concerned officials certify the rectification before resuming manufacturing. The process takes anywhere between 20 days to two months, depending on the inspection. In some cases, critical observations like non-functional air handling units and faulty equipment in micro labs were found in these firms in the joint inspection. Major issues like verification of machinery are also checked during inspection, as it is observed that many firms do not maintain their machinery properly, which adversely affects the quality of medicines. To ensure the manufacture of quality medicines, the state and central drug regulatory authorities have taken action against 13 pharmaceutical units located in various industrial clusters of Himachal for non-adherence to quality parameters. These firms, located in Baddi, Nalagarh, Solan and Sansarpur Terrace, have been directed to shut down manufacturing operations or their licences will be suspended. While the licences of seven firms may be suspended and their manufacturing operations completely stopped, six others are facing partial suspension of drug production under specific sections after deficiencies were found in their manufacturing protocols. Officials of the state drug authorities and Central Drugs Standard Control Organisation (CDSCO) had conducted risk-based inspections of 42 firms in various industrial clusters since May this year. The inspections found several deficiencies, including lack of regular maintenance of equipment. State Drug Controller Manish Kapoor said the state and central regulatory authorities are conducting risk-based inspections in pharmaceutical units. He said, “Firms whose names frequently appear in the monthly drug alert and their products are found to be not of standard quality are subjected to special inspection. Actions like partial or complete shutdown of production are taken against them depending on the severity of the deficiencies.” Since there are 650 drug units operating in the state, the number of samples of products not meeting quality standards in the monthly alert is usually high. In the alert issued in October, 25 drug samples, including 11 injections, were found not conforming to quality standards. After the firm takes action as per the inspection, it is re-inspected and the concerned officials certify the rectification before resuming manufacturing. The process takes anywhere between 20 days to two months, depending on the inspection. In some cases, critical observations like non-functional air handling units and faulty equipment in micro labs were found in these firms in the joint inspection. Major issues like verification of machinery are also checked during inspection, as it is observed that many firms do not maintain their machinery properly, which adversely affects the quality of medicines.