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HPMA urges health minister to stop risk-based inspections at manufacturing sites of MSMEs for one year
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Peethaambaran Kunnathoor, Chennai
December 28 , 2023
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The Haryana Pharmaceutical Manufacturers Association (HPMA) has urged Union health minister Dr. Mansukh Mandaviya to suspend the risk-based inspections being carried out by the CDSCO at the manufacturing plants of the small and medium scale pharma industries for one year, or extend the deadline for introduction of the Revised Schedule M upto two years.
The association leaders informed the minister that the risk-based inspections being carried out by the CDSCO officials at the manufacturing sites are not in any way facilitating the industry players, but disturbing them very much. The MSMEs need financial support and extension of time-limit for complying with the new schedule. Moreover, the deadline given for the introduction of the new schedule is not sufficient for small pharma manufacturers in entire India, so it has to be increased to a minimum period of two years.
A delegation of entrepreneurs from Haryana under the leadership of HPMA president RL Sharma met the minister last week and briefed him of the problems faced by the small industrial units in the state in the backdrop of the new Schedule M reforms by the central regulators.
Sharing information with Pharmabiz, RL Sharma said the CDSCO has to act as facilitator and guide rather than regulators. They should guide the pharma MSMEs in the country for the next one year and not act as regulatory officers. Further the industry needs financial support from the government to improve the infrastructure facilities as per the new guidelines and to suit the WHO GMP standards. He said the CDSCO has given one year time to improve the facilities, but it is not sufficient for the MSME sector. Meanwhile, the CDSCO is carrying out the inspections. It has to be stopped for one year, he wanted.
Sharma said the minister has assured the delegation that he will look into the problems raised by the industry leaders and encouraged them to improve their facilities by moving at a slow pace. “The minister took a keen interest in paying attention to the drug manufacturers of Haryana and he encouraged us very much to go with the industry to manufacture quality pharmaceuticals. It was a wonderful experience meeting him at his office in New Delhi. He offered all help and support to the pharma MSMEs in Haryana, and we are hopeful of positive responses to our demands from his office. We also needed some financial support for the transition from the present standard to the new schedule”, said Sharma.
Apart from these demands the HPMA wanted the minister to retain the CDSCO’s office in Ghaziabad itself because the city is very near to Karnal, the pharma hub in Haryana. From Ghaziabad it is very easy to reach Baddi and Sonipet, the pharma centres in the northern parts of the country. Sharma said the minister advised them to focus on the quality of the medicines and not to worry about the concerns of the industrial sector. All the members in the delegation were fully satisfied with the response of the minister, he added.
The delegation included the general secretary of HPMA, Vikas Pruthi, Vineet Gupta and Rohit Gupta, executive members of the association.
CDSCO started the risk-based inspections at the production sites of the manufacturing companies last year following a warning by the WHO, and also by the US FDA on quality aspects of Indian made drugs. The warnings were given because of the unfortunate incidents that occurred in foreign countries allegedly after consuming medicines exported from India.
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