New Delhi: Stung by a series of episodes that have brought the credibility of Indian drugmakers under the scanner, the Union government is asking pharmaceutical companies across India to adopt an updated good manufacturing practices (GMP) framework that has been described as more thorough, ThePrint has learnt.
The GMP for pharmaceutical manufacturing units is part of Schedule M of the Drugs and Cosmetics Act, 1940.
GMP are mandatory standards aimed at bringing quality into products by way of specific requirements and checks with respect to materials, methods, machines, processes, personnel and facility or environment etc.
The revised framework was shared with associations of pharma companies by the Central Drugs Standard Control Organisation (CDSCO) at a meeting last week, government officials said.
At the meeting, the officials added, the drug regulator sensitised the pharma companies about the requirements around the revised Schedule M, saying some of them are a notch above the GMP prescribed by the World Health Organization (WHO).
The directive comes after a number of Indian drugmakers hit the headlines over the past year for quality issues. These include small- and medium-scale drugmakers exporting drugs — mainly cough and cold syrups — to countries in Africa and Asia, as well as major companies exporting generic drugs to countries such as the US.
The associations that joined the meeting included the Organisation of Pharmaceutical Producers of India (OPPI), a network of MNC pharma companies, the Indian Pharmaceutical Alliance (IPA), a group of research-based Indian drugmakers, and the Indian Drug Manufacturers’ Association (IDMA), an association of small and medium pharma units in the country.
The latest update to Schedule M includes asking drugmakers to ensure sanitation requirements covering equipment and apparatus, production materials and contents, apart from personnel and premises. The previous norms focused only on workers and the premises.
Also, the companies are being asked to report all details related to faulty manufacture, product deterioration, and serious quality problems to the licensing authorities. This was earlier applicable only in case of serious adverse events.
Under the revised GMP requirements, companies have been asked to carry out self-inspections, quality audits and supplier audits and approval at least once a year. Earlier, the rules only called for occasional audits.
“This particular provision is not there even in WHO-GMP for pharma units,” said a pharmaceutical expert who did not wish to be named.
There are about 10,500 drug manufacturing units — majority of them with an annual turnover of less than Rs 10,000 crore — in the country. A document prepared by the Union health ministry and accessed by ThePrint shows that nearly 80 percent of small- and medium-size companies do not implement Schedule M in order to keep the cost of production low.
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Fixed timeline
The government had earlier announced that all drugmakers with an annual turnover of over Rs 250 crore will have to mandatorily adopt GMP within six months, starting 1 August this year. Companies with a turnover of less than Rs 250 crore were given a year to complete the process.
The GMP were first incorporated in Schedule M in 1988 and the norms were last amended in 2018. The revised Schedule M that the drugmakers are now being asked to adopt have further been improved, a senior official in the health ministry told ThePrint.
IDMA president Viranchi Shah, who was present at the CDSCO meeting, conceded that many companies under the association did not follow GMP requirements, but stressed that the government had shown willingness to handhold.
“We are hoping that the majority of the companies will fall in line with the changed norms — those which don’t may be weeded out eventually,” he said.
According to data shared by the health ministry last week, during a drive to crack down on faulty drug manufacturing, the authorities inspected 162 units and 14 public testing labs over six months.
Major issues detected during these inspections included poor documentation, lack of process and analytical validations, absence of self-assessment, quality failure investigation, and internal product quality review, no testing of raw material, lack of infrastructure to avoid cross-contamination, absence of professionally qualified employees, and faulty design of manufacturing and testing areas.
(Edited by Sunanda Ranjan)
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