With small and medium-sized pharmaceutical companies facing increased scrutiny from global regulators due to recurring lapses, the Narendra Modi government is planning to handhold these drugmakers.
The central government has designed “capacity-building workshops” to assist drugmakers in navigating the regulatory requirements effectively.
The concept of the workshop was proposed by the Ministry of Commerce and Industry’s pharmaceutical export wing, Pharmexcil, which has been working with the Ministry of Health and Family Welfare to improve the good manufacturing practices of MSME drugmakers.
The workshop will be conducted in collaboration with the country’s apex drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO), an arm under the Health Ministry which regulates the quality and standard of drugs in India.
The one-day regional workshop, which will be held in hybrid mode, will be launched in more than 10 locations across India with the inaugural workshop starting in Delhi on Friday, September 15. The other planned locations include Ahmedabad, Hyderabad, Chandigarh, Indore, Chennai, Bangalore, Mumbai, Sikkim, Visakhapatnam and Goa. The second workshop is planned for September 16 in Baddi and Hyderabad.
Why Do MSMEs Need Handholding?
The move is triggered by complaints over the quality of Made-in-India medicines raised by multiple global health regulators, including the World Health Organisation, Uzbekistan, the Gambia, the United States, Marshall Islands and Micronesia.
“With the recent WHO Medical alerts and back-to-back reporting of cases involving fatalities brought on by supply of contaminated medications by some of the Indian companies have surfaced the non-compliance by these units to the GMP and the product quality norms,” Uday Bhaskar, director general, Pharmexcil told News18.
He said these incidents should not come as a “rude shock” as there have been numerous cases which are “tarnishing the image of the Indian pharmaceutical industry”.
“There have been numerous cases in the past wherein it was noticed that there has been a particular pattern in these incidents by the MSMEs,” Bhaskar added.
He explained that the objective of the planned “capacity building program” is to create awareness of best international practices for pharmaceutical manufacturing, “aiding them in maintaining the quality of the medicaments that they produce and to further elevate the image of the Indian pharma industry.”
According to government data, there are around 10,500 manufacturing units in the country, of which at least 8,500 are in the category of micro, small and medium enterprises (MSME). Of these, only 2,000 are approved by the World Health Organization and certified as WHO-GMP (Good Manufacturing Practices).
In August, the central government decided to implement ‘Schedule M’ across all companies to tighten the manufacturing practices of pharmaceutical companies in India.
Ensure Maximum Participatio, DCGI Requests Drugmakers
The letter written by the Drug Controller General of India (DCGI), chief of CDSCO, dated September 14, informs all drug manufacturing associations about the schedule of planned workshops across India.
“It is decided to conduct a one-day regional workshop across India for dissemination of Revised Schedule M requirements to all stakeholders… The tentative schedule of the workshop to be held at Delhi, Ahmedabad, Mumbai, Hyderabad, Kolkata and Baddi in the month of September 2023 is annexed,” said the letter seen by News18.
The regulator requests to “sensitise all members of your association to attend and ensure maximum participation in the workshop on the dates mentioned in the annexure.”
“In case members are not able to attend physically may attend virtually. The concerned CDSCO zonal office will coordinate with you in this regard,” it added.
Comments
0 comment