Drugmakers must ensure good manufacturing practices

The new guidelines come against the backdrop of deaths reported in certain countries such as Gambia in Africa that were linked with consumption of Indian drugsAll drugmakers in India must comply with fresh guidelines to ensure good manufacturing practices, the central government said in a notification in the wake of complaints of substandard medicines exported from the country.Under the new Schedule M of the Drugs and Cosmetics Act of 1940, notified on December 28, a manufacturer will be held 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’’. Pharmaceutical firms will also have to intimate drug licensing authorities about recalling a drug and also report product defects, deterioration or faulty production.The new guidelines come against the backdrop of deaths reported in certain countries such as The Gambia in Africa that were linked with consumption of Indian drugs.

The amended guidelines stress the need for stability testing of drug substances in accordance with recommended climate conditions with an aim to upgrade small and medium enterprises at par with global standards and ensure production of internationally 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 revised guidelines said.

The licensee will also have to have a vigilance system in place for collecting, processing and forwarding the reports to licensing authorities for information on adverse drug reactions.

Industry experts welcomed the step, saying that it will help improve the drug quality management ecosystem.

“The revised regulations of Schedule M will help ensure compliance with international quality standards and will benefit both patients and the industry by promoting the manufacturing of safe, effective and high-quality drugs,” said Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, a lobby group. “The focus on risk management, qualification and validation of equipment, and self-inspection will be a vital contribution.”For a smooth transition from the current rules to the revised ones, the health ministry has provided a transition period of six to 12 months for large manufacturers (with over ₹250 crore turnover) and smaller firms (less than ₹250 crore turnover).

Good manufacturing practices are mandatory quality standards that require control on materials, methods, machines, processes, personnel and facility and environment among other things. They were first incorporated in Schedule M in 1988 and the last amendment was done in June 2005.

There are nearly 10,500 drugmakers in the country, out of which around 8,500 are small and medium companies, according to health ministry data. India is a major exporter of medicines to low and middle-income countries that require safe manufacturing certification. There are an estimated 2,000 small and medium companies that have such certification.The Central Drugs Standard Control Organisation has inspected 254 manufacturing units and 112 public testing labs in the past few months. Major issues found the inspections include poor documentation, lack of process and analytical validation, 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, among others.

In 2018, a draft notification was issued to upgrade and synchronise Schedule M to international standards based on the recommendations of the Drugs Technical Advisory Board. A large number of comments and suggestions were received from stakeholders.

Some of the major changes in the new rules include introducing Pharmaceutical Quality System, Quality Risk Management, Product Quality Review, qualification and validation of equipment, change of control management, self-inspection and quality audit team, supplier audit and approval, stability studies as per recommended climate condition, and validation of practices related computerized system.

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