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PDMA to organise workshop on Revised Schedule M on July 13 in Pondicherry
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Peethaambaran Kunnathoor, Chennai
June 18 , 2024
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To provide insights into the provisions of the Revised Schedule M for the pharmaceutical industries, the Pondicherry Drug Manufacturers Association (PDMA) is planning an exclusive workshop on Schedule M, tentatively on July 13 in Pondicherry.
Over one hundred technical persons from 60 drug manufacturing companies will be trained by experts from CDSCO and regulatory bodies about the new provisions of the GMP. Personnel from the departments of production, quality control, quality analysis and regulatory will attend the one-day seminar-cum-workshop, said M Pramod, chairman of the PDMA.
Saying that the list of speakers will be finalized soon, he said the objective of the program is to educate the members of the association about the revision of the GMP. This is the first time the Union Territory's drug manufacturing companies getting insights on quality upgradation as designed by the CDSCO. The workshop is supported by the central and the state regulatory agencies. The deputy director of the Chennai zone CDSCO, Dr. K Srinivas and the drug controller of Pondicherry, Dr. Anandakrishnan will be the chief guests.
P Ramesh Kumar, president of PDMA, said there are some amendments now in the GMP, about which the manufacturers, especially of the MSMEs, need to understand. In Pondicherry, most of the drug manufacturing companies come under the MSME sector.
Commenting on the program, the DC of Pondicherry, Dr. Anandakrishnan, said the technical persons in the industry must know about the revisions that include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and the new categories of drugs. He said the CDSCO has introduced the new provisions because of several incidents of contamination and substandard drugs exported previously from India.
He further said, along with larger companies the MSME units also need to bring their manufacturing processes at par with global standards. The Central government has allotted one year time for the MSMEs to make changes in their production facilities.
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