Govt notifies new drug-making standards after overseas deaths, gives firms up to a year to implement

The notification comes months after the Union Health Minister urged pharmaceutical companies to begin implementing these standards, which are on a par with those set by the World Health Organisation (WHO).

Large companies, which have a turnover of more than Rs 250 crore, will now have to implement the guidelines within the next six months. Small and medium manufacturers, which have a turnover of less than Rs 250 crore, will get a year.

There are nearly 10,500 drug manufacturing units in the country. Of them, 2,000 large companies that export medicines are already WHO-GMP compliant.

But an industry participant, who declined to be named, said: “We had hoped for a two-year window for small companies to comply with the requirements. A lot of infrastructure modifications that are capital intensive will be needed. As for the bigger companies, they are already WHO-GMP compliant.”

The draft guidelines were released in 2018. Ensuring compliance with international GMP standards was one of the recommendations made during a Health Ministry brainstorming session early last year following reports of a string of international incidents where Indian syrups and eye drops were allegedly found to be contaminated. The deaths of 70 children in the Gambia, 18 children in Uzbekistan, three people in the United States and six people in Cameroon have been linked to these products.

A risk-based assessment of 254 manufacturing units and 112 public testing labs by the apex drug regulator found poor documentation and a wide range of deficiencies — in process and analytical validations, self-assessment, failure investigation, internal quality review, testing of incoming raw material, infrastructure to avoid cross-contamination, professionally qualified employees and faulty design of manufacturing and testing areas.

The revised GMP guidelines focus on quality control, proper documentation and IT backing to maintain the quality of medicines produced. It also creates a recall mechanism for drug manufacturing companies. “Recall operations shall be capable of being initiated, so as to effectively reach at the level of each distribution channel,” said the notification dated December 28. The licensing authority also has to be informed of any intention to recall a product if it is suspected to be defective.

The new guidelines require companies to carry out regular quality reviews of all its products, verify consistency of the quality and the processes, thorough investigation of any deviation or suspected defect and implementation of any preventive actions. It also says that all changes that may affect the production or quality of the product must be validated first.

The guidelines also state that companies should have GMP-related computerised systems, which ensure that there is no tampering of data related to the processes. In addition, the new schedule M also lists out the requirements for additional types of products, including biological products, agents with radioactive ingredients or plant-derived products.