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TN to become role model for other states in executing guidelines of revised cGMP: Dr SV Veeramani
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Peethaambaran Kunnathoor, Chennai
October 25 , 2023
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Tamil Nadu will become the role model for other states in India in executing the guidelines of the new Schedule M (Revised Good Manufacturing Practices) in the pharma manufacturing sector and it is committed that within the prescribed time limit all the manufacturing companies including the small scale units will upgrade their production facilities as per the notifications, said Dr SV Veeramani, a pharma entrepreneur from Tamil Nadu.
Presenting the opening remarks at the inaugural session of the ‘Regional Workshop on the proposed Revised Schedule M’ organized by the CDSCO with the support of the TN IDMA, Dr Veeramani said the initiative of the Drug Controller General of India to give a pre-awareness on the soon-to-be-notified New cGMP will enlighten the small-scale manufacturers of the state to improve their technical capacities in the manufacturing process. He said the new guidelines will be almost equal to the WHO-GMP guidelines and they will be helpful for the Indian pharmaceutical sector to become on par with international standards.
Speaking on the sidelines of the programme, Dr. Veeramani who is also the chairman of the Pharmaceuticals Export Promotion Council, told Pharmabiz that the Tamil Nadu pharmaceutical manufacturers were fully committed to manufacture quality and efficacious medicines for the patients of over 200 countries on the globe. Since India is marketing medicines to almost all the countries in the world, the responsibility of the manufacturing companies is greater and all the drug manufacturers in the state are very much conscious about it. He further pointed out that the coming changes in the good manufacturing practices will definitely boost the standards of the drug manufacturing in India and it will be a good move in the entire pharma domain.
Dr KM Srinivasan, south zone deputy director of the CDSCO while delivering his keynote speech on the new cGMP, said awareness on good manufacturing practices will reduce the number of NSQ drugs and create uniformity in implementing the guidelines of the Schedule M. He said the fundamental aim of the GMP is to maintain the standards of the production process and strengthen the quality of the products. As far as the Indian pharmaceutical companies are concerned, there are very few companies which are not following the GMP standards. India has better regulations which show that the public health of the country is stronger, he said.
M N Sridhar, deputy director of the drug control department in Tamil Nadu, who was the guest of honour at the function, said the new cGMP becomes relevant in India at a time when the country is reinforcing itself to become a global pharmaceutical hub. As regards regulation of drug rules in the pharma sector he said several NSQs are found in the inspections carried out by the drug inspectors and in the last one year, the department conducted six joint inspections and show cause notices were issued to multiple companies. He said India’s global position in the pharmaceutical sector is created through the quality of the products. He expressed the hope that hereafter all the manufacturing companies in the state will focus on international quality and try to reduce the number of sub-standard drugs.
Dr. M Manivannan, deputy director at the CDSCO in New Delhi and president of the Tamil Nadu IPA was also present on the dais. He said the CDSCO and the Indian pharmaceutical sector are expecting the notification of the revised GMP guidelines at any time from now and it will be a ‘Diwali Gift’ for the pharma sector from the Central government. The GMP workshop series being organized by the central regulator prior to the notification of the new guidelines is the brainchild of the present DCGI and it is a good initiative to equip all the manufacturing companies in the country to be ready for complying with the new guidelines. The government of India and the CDSCO will implement the revised guidelines in one year soon after it was notified, he said.
J Jayseelan, chairman of the TN IDMA, who made the introductory speech and welcomed the dignitaries on the dais, said the pharmaceutical industries in Tamil Nadu are ready to meet all the challenges with regard to implementation of the coming guidelines and also ready to cooperate with the Central and state drug regulators.
Dr T Sathish, vice-president of the TN IDMA introduced the speakers and dignitaries to the audience. Seven hundred industry representatives attended the program at the hall and over one thousand people watched it online. The DCGI, Dr. Rajivsingh Reghuvanshi was the chief guest at the function and he delivered the inaugural address.
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