For not adhering to quality, 13 firms directed to stop drug production

To ensure the manufacturing of quality drugs, the state and Central drug regulatory authorities have taken action against 13 pharmaceutical units located in various industrial clusters of Himachal for not adhering to quality parameters.

These firms located in Baddi, Nalagarh, Solan and Sansarpur Terrace have been directed to stop manufacturing operations or their licences will be suspended. While the licences of seven firms may be suspended and their manufacturing operations completely halted, six others face partial suspension of drug production under specific sections after shortcomings were noticed in their manufacturing protocols.

The state drug authorities and officials of the Central Drugs Standard Control Organisation (CDSCO) had undertaken a risk-based inspection of 42 firms in various industrial clusters since May this year. Several shortcomings were noticed in the inspections, including the lack of regular maintenance of equipment. State Drug Controller Manish Kapoor said that the state and central regulatory authorities were randomly conducting risk-based inspections in pharmaceutical units. "The firms that often figure in the monthly drug alerts and their products are declared not of standard quality are specially inspected. Depending on the gravity of the shortcomings, action like stop production partially or completely was taken against them," he added.

As 650 pharmaceutical units are operating in the state, the number of drug samples figuring in the monthly alerts comprising products failing quality parameters is usually high. In an alert issued in October, 25 drug samples, including 11 injectables, were found not conforming to quality parameters.

A firm is re-examined after it takes action as per the observation, and the officials concerned certify the rectification before it is allowed to restore manufacturing. The process takes 20 days to two months, depending upon the observations made.

In some cases, critical observations like non-functional air handling units and dysfunctional equipment in micro labs in these firms were detected in joint inspections. Key issues like the validation of machinery is also examined during inspections, as it has been observed that many firms do not properly maintain their machinery, adversely affecting the quality of drugs.

42 forms inspected

• While the licences of seven firms may be suspended and their manufacturing operations completely halted, six others face partial suspension of drug production
• The state drug authorities and officials of the Central Drugs Standard Control Organisation (CDSCO) had undertaken a risk-based inspection of 42 firms in various industrial clusters since May this year