In a bid to make the pharma industry accountable and ensure quality drugs, the Union Health Ministry has notified the Revised Schedule M guidelines under which pharmaceutical firms 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.
The move comes in the wake of complaints of sub-standard Indian drugs and deaths abroad in the recent past. In fact, data available from the Central Drugs Standard Control Organisation (CDSCO) report based on testing of samples in various states across the country had found that at least 6 per cent of cough syrup samples belonging to 54 Indian pharmaceutical manufacturers failed the mandatory quality test for export till October 2023.
The notification aims to tighten the noose around the pharma companies as 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 December 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”.
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,” as per the guidelines.
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.
There are around 10,500 manufacturing units in the country out of which around 8,500 fall under the MSME (Micro, Small & Medium Enterprises) category. India is a major exporter of medicines to low/middle-income countries (LMICs) 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 stated.
The Central Drugs Standard Control Organisation (CDSCO) 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 expectations at par with global standards, specially to those of WHO, and ensure production of globally acceptable quality of drug,” the official said.
