|
By end 2024 all manufacturing units in Pondicherry will be ready to adhere to revised Schedule M norms: PDMA
|
|
Peethaambaran Kunnathoor, Chennai
April 25 , 2024
|
|
|
By the end of 2024 all the drug manufacturing units in the Union territory of Pondicherry will become fully complied with the revised Schedule M norms and the pharmaceutical products manufactured in the Union territory will be at par with global standards, says P Ramesh Kumar, president, Pondicherry Drug Manufacturers’ Association (PDMA).
“We started the process two years ago when the CDSCO’s first announcement came. All the deficiencies will be rectified in another six to eight months time as per the regulations of the revised GMP. Even now we are complying with 90 per cent of the norms, and there are only some small-small gaps which will be addressed very soon. We are getting all support from the state regulatory office and the UT government, and regularly we insist our members to complete the process as early as possible”, he told Pharmabiz.
Fortunately, the drug manufacturers in the UT are getting all files cleared within a week’s time from the office of the drugs control department. There is no delay in receiving the CoPP or Free sale certificates or product endorsement or renewals or special product permission for export purposes. If one manufacturer or exporter applies for one certificate, the process will be ready in 2 to 7 days. The industry is very much thankful to the drug control department, Kumar said.
He said the drug inspectors from the DCA are regularly inspecting the manufacturing facilities and whenever a new application is submitted for any certificate or for GMP renewals, it will be issued only after the inspection on the manufacturing site. The DCA is strict on their regulations and in the same way they are helpful to the industry.
At present the union territory has 75 drug manufacturers and all of them come under the small and medium enterprises category. The regulatory department is very vigilant after the crackdown on spurious and substandard drugs in Pondicherry by central authorities ten years ago. In the same way, the industry is also cautious and trying to adhere to all regulatory norms. That is why; the manufacturers are keeping one step ahead in implementing the revised rules of the GMP. The association is conducting workshops and training to the industry people every month to give awareness on the revised Schedule M.
In the middle of June a one-day programme will be conducted involving all stakeholders of the industry focusing on various aspects of the production process. In the program we would like to invite the DCG of India as the chief guest. However, deputy directors of the CDSCO south zone, commissioner of the FDA in the union territory, drug controller E Anandakrishnan and regulatory officers and resource persons from Chennai and Karnataka will be invited. The program will be finalized soon.
For a complete overhaul of the Pondicherry pharmaceutical industry sector, PDMA wants to conduct one three-day Exhibition-cum-B2B Seminars in the month of August this year. The association is planning to approach the Pharmexcil for its support for holding the programme which was to have been held in the month of December, but due to IPC in December, we are preponing it to August, said the PDMA president.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|