Pharma Industry to Achieve Global Standards with Schedule M Compliance

April 25, 2024

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Last Updated on May 4, 2024 by The Health Master

Schedule M

All drug manufacturing units in the Union Territory of Pondicherry are expected to achieve full compliance with the revised Schedule M norms, a move that will elevate the quality of pharmaceutical products manufactured there to meet global standards by end of 2024.

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Revised GMP Compliance

This positive development is attributed to the proactive measures taken by the Pondicherry Drug Manufacturers’ Association (PDMA) led by its president, P Ramesh Kumar.

“We initiated the process two years ago, soon after the CDSCO’s initial announcement,” says Kumar.

“Any remaining deficiencies will be addressed within the next six to eight months, adhering to the revised Good Manufacturing Practices (GMP) regulations.”

He further clarifies, “Currently, we are already compliant with 90% of the norms. Only minor gaps exist, which will be swiftly rectified.”

“The state regulatory office and the UT government have been incredibly supportive throughout this process.”

“We constantly encourage our members to complete the compliance process at the earliest.”

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Regulatory Processes and Efficient Support

A significant advantage for Pondicherry’s drug manufacturers is the efficient regulatory framework.

“Fortunately, applications submitted by manufacturers and exporters to the drugs control department are processed and cleared within a week,” highlights Kumar.

“This applies to Certificates of Pharmaceutical Product (CoPP), Free Sale Certificates, product endorsements, renewals, and special product permissions for exports. Processing times range from 2 to 7 days, ensuring minimal delays.”

Strict Vigilance

The Drug Control Authority (DCA) plays a crucial role in maintaining quality standards.

“Drug inspectors from the DCA conduct regular inspections of manufacturing facilities,” explains Kumar.

“New applications for certificates or GMP renewals are only issued after thorough on-site inspections.”

“The DCA adheres to strict regulations, but they are also supportive of the industry’s efforts.”

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Focus on Continuous Improvement

Given the past crackdown on substandard drugs in Pondicherry, both the regulatory bodies and the industry are particularly vigilant.

The UT currently houses 75 drug manufacturers, all categorized as Small and Medium Enterprises (SMEs).

“The industry is committed to adhering to all regulatory norms,” emphasizes Kumar.

“This is why manufacturers are proactively implementing the revised GMP rules.”

“The PDMA conducts monthly workshops and training programs to educate industry personnel on the latest requirements of Schedule M.”

Upcoming Industry Events

To further propel the industry’s growth, the PDMA is organizing key events.

“A one-day program in mid-June will bring together all industry stakeholders to discuss various aspects of the production process,” reveals Kumar.

“We are aiming to invite the Drug Controller General of India (DCGI) as the chief guest.”

“Additionally, deputy directors of the CDSCO south zone, the UT’s FDA commissioner, drug controller E Anandakrishnan, and regulatory officers from Chennai and Karnataka will be invited.”

“The program details will be finalized soon.”

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B2B Seminars for August

With a vision for a complete overhaul of the Pondicherry pharmaceutical sector, the PDMA is planning a three-day Exhibition-cum-B2B Seminar in August 2024.

“We intend to seek support from Pharmexcil, the apex body of Indian Pharmaceutical exporters, for this event,” says Kumar.

“Originally planned for December, we have rescheduled it to August due to potential conflicts in December.”

This series of initiatives by the PDMA and the supportive regulatory environment position the Pondicherry pharmaceutical industry for a successful transition to global standards.

By achieving full compliance with Schedule M by the end of 2024, the industry is poised to become a reliable source of high-quality pharmaceuticals, not just domestically but also on the international stage.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.