Government Notifies Revised Schedule M Guidelines For Pharma Manufacturing Units

New Delhi, Jan 6 (PTI): The Union Health Ministry has notified the Revised Schedule M guidelines under which pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production.

Till now there was no provision for informing the licensing authority about drug recall.

Schedule M part of Drugs and Cosmetics Act 1940 deals with 'Good Manufacturing Practices' to be followed by pharmaceutical manufacturing units in the country.

The new guidelines issued on Dec. 28 state the manufacturer must be responsible for the quality of the products so that 'they are fit for their intended use, comply with the requirements of the licence, and do not place patients at risk due to inadequate safety, quality or efficacy'.

These guidelines come against the backdrop of complaints of sub-standard Indian drugs and deaths abroad reportedly due to it since 2022.

The amended guidelines stress the need for stability testing of drug substances in accordance with recommended climate conditions with an aim to upgrade MSMEs at par with global standards, especially to those of WHO, and ensure production of globally acceptable quality of drug.

It also specifies that release of the finished product is conditional upon satisfactory results of these tests.

"The licensing authorities shall be informed if a manufacturer is considering action following the faulty manufacture, product deterioration, a suspect product or any other serious quality problems with a product," the new guidelines read.

Besides, the licensee shall have a pharmacovigilance system in place for collecting, processing and forwarding the reports to the licensing authorities for information on the adverse drug reactions emerging from the use of drugs manufactured or marketed by the licensee.

In order to have smooth transition from the present Schedule M to revised Schedule M, it has been decided to provide a transition period of six and 12 months for large manufacturers (over Rs 250 crore turnover) and MSMEs (less than Rs 250 crore turnover), respectively.

Good Manufacturing Practices are mandatory standards which build and bring quality into product by way of control on materials, methods, machines, processes, personnel and facility/environment etc.

The GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June, 2005.

There are around 10,500 manufacturing units in the country out of which around 8,500 fall under the MSME category. India is a major exporter of medicines to low/middle-income countries which require WHO GMP certification, an official said.

"We have around 2,000 units in the MSME category in the country having WHO GMP certification," he said.

The pharmaceutical manufacturing and quality domain has developed and progressed significantly in last 15-20 years.

"Our understanding of the domain has increased because of development in pharmaceutical and manufacturing sciences. Linkage between manufacturing and product quality and interdependence between the two has been established," the official explained.

Also, observations from ongoing Risk Based Inspections further reiterated the need to have a relook at the current GMP regulations and Quality Management Systems being followed by pharmaceutical manufacturers, the official stated.

The Central Drugs Standard Control Organisation has inspected 254 manufacturing units and 112 public testing labs in the last few months.

Major issues found during RBI inspections are poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation, absence of internal product quality review, absence of testing of incoming raw material and faulty design of manufacturing and testing areas etc, the official said.

"Based on the above factors and to keep pace with fast changing pharmaceutical manufacturing and quality domain, there was a necessity to revisit and revise the principles and concept of GMP mentioned in current Schedule M. This would bring our GMP recommendations and compliance expectation at par with global standards, specially to those of WHO, and ensure production of globally acceptable quality of drug," the official said.

Accordingly, based on the discussion and recommendation of the Drugs Technical Advisory Board, a draft notification was issued on October 2018 to upgrade and synchronize the Schedule M comparable to international standards.

Large number of comments/suggestions were received from various stakeholders and after review and multiple consultations with them, the draft revised Schedule M was published.

Some of the major changes which will happen with introduction of revised Schedule M to support upgradation of the units are introduction of Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), Qualification and Validation of equipment, Change control management, Self-inspection and Quality audit team, Supplier audit and approval, Stability studies as per recommended climate condition, Validation of GMP related computerized system and Specific Requirements for Manufacturing of Hazardous products etc.

"The revised guidelines will address most deficiencies related to documentation, failure investigation and technically qualified personnel with right person doing the right job. It will support development of robust quality management system in the company thereby enabling production of globally acceptable quality medicine," the official said.