|
TN PMA asks state govt to approach Central govt to provide 3-year time to implement Revised Schedule M
|
|
Peethaambaran Kunnathoor, Chennai
January 22 , 2024
|
|
|
The Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA), an organisation of 155 micro and small drug manufacturing companies, has approached the state government with a request to take their concerns with the central government with regard to adoption of the Revised Schedule M.
The office-bearers of the association met the principal health secretary Gagandeep Singh Bedi and apprised him of the issues of the small-scale pharma entrepreneurs in implementing the revised rules within 12 months. It is learnt that the health secretary has directed the JDC of the drug control administration, who is the controlling authority, to prepare a draft of the letter in discussion with the industry to be submitted to the central government.
Meanwhile, the association has directly given one letter to the Union Health Minister and to the Drug Controller General of India (DCGI) urging them to give a period of three years to fully comply with the new GMP.
Talking to Pharmabiz, TN PMA president MD Varadarajan said they have shared their concerns and demands with the JDC, M Sreedhar, who wanted them to give the issues in writing. Accordingly, Varadarajan has prepared a memorandum which will soon be given to the joint director. He said he agrees with the idea of tightening the GMP norms for pharma firms by the government for better quality standards and strict compliance with the rules, but he requires more than the period already announced.
“We (TN PMA) are organizing a seminar in the first week of February to discuss everybody's problems in adopting the new rules. All our members are ready to upgrade their quality standards and production facilities, but all of them have very low turnover. For the transition to the WHO’s prescribed standards by the MSME units, they need more time. We want a two-year period in addition to the one year officially granted,” said Varadarajan.
Meanwhile, JDC Sreedhar said the PMA office-bearers have visited him and shared their concerns. As far as the new GMP norms, it is introduced by the government of India and all the pharma firms are responsible to follow the guidelines. Regarding extension of the implementation period, he said if the central government extends the period it will be good for the MSME units, but Schedule M will be made compulsory for all the manufacturing units.
Commenting on the revision of the GMP guidelines, HDV Vora, managing director of the Panvo Organics Pvt Ltd in Chennai and a whistleblower of pharma MSMEs problems, said the new GMP rules will make better quality, better products and better compliance. It will improve not only the quality but also the stability of the products. Those who have better Schedule M standards, they will be able to manufacture products for big companies and MNCs. The revision is helpful for doing better things and everybody must improve their standards. As regards the timeframe, he said the industry can ask for some more time from the government for upgrading their standards. According to him, he has benefited out of the revised Schedule M and WHO GMP standards and working for corporate companies.
M Rajaratinam, the immediate past president of the TN IDMA and managing director of the MMC Pharmaceuticals in Chennai, said if India has to keep the adage that ‘India is the Pharmacy of the World’ the pharma sector has to improve in line with global standards. He said the Tamil Nadu pharma industry welcomes the new guidelines introduced by the Central government to increase the quality standards of the drug products, but the industry requires only an extension of time. “We are ready to change and upgrade our production standards, only thing we want is a longer period of three years,” he told Pharmabiz.
A P Vaitheeswaran, director of Aeon Formulations in Chennai, said although the objective of the Revised Schedule M is to improve the quality standards of manufacturing companies, it is not conducive to the small and micro units (SSI). In the present condition, the new guidelines will abolish the SSI pharma units. If small scale units have to survive, the government must give time and financial support to the small companies. He said all kinds of medicines are available in each and every part of the country because of SSI units which manufacture the products for the popular companies.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|