Drug Officials Inspect Pharma Firms in AP
Stress on compliance with updated Good Manufacturing Practices
Vijayawada:The drugs control department has started inspection of nearly 400 pharmaceutical companies involved in manufacture of bulk drugs and formulations in AP.
This is to ascertain whether they are following the updated Good Manufacturing Practices (GMP) as per norms of the recently revised ‘Schedule M’ of the Drugs and Cosmetics Act, 1940.
Teams of drug inspectors under the supervision of senior officers like assistant directors and deputy directors have started visiting the pharma firms, which are having their annual turnover at less than `250 crore each, and which are not inspected in the last one year; and those that have not sought any exemption from implementation of the revised Schedule M up to Dec 31, 2025.
Notably, its implementation has begun from January 1 this year.
The drug inspectors would check whether the pharma firms are complying with the SOP as per revised GMP. These include: upgrading the manufacturing processes, installation of state-of-the-art manufacturing equipment, use of proper raw materials and also maintenance of records besides refining the whole process from procurement of raw materials to releasing the final product into the market.
The move seeking compliance with revised Schedule M’ is aimed to enhance quality of Indian pharmaceuticals to international standards and to ensure that they are safe, effective and of high quality, officials claimed.
AP has 400 pharmaceutical units including the small and medium units. The authorities have fixed a target to complete the inspection in a month’s time.
It takes one to two days or even more for inspection of each pharmaceutical unit. The drug inspectors have to find out compliance with the revised norms, deviations and violations. Once anomalies are noticed, the authorities would serve a show cause notice and wait for the response. Based on this, action would follow.
A senior DCA official claimed, “We have not found any major deviations so far.”
DCA has ruled out any major issues of quality with cough syrups in AP as the banned ones are not being supplied in the state.
