Indian Pharma Industry: Chasing a mirage called Good Manufacturing Practices

The objective of GMP is to ensure the quality, safety, and efficacy of pharmaceutical products.

Separate incidents of the death of 66 children in The Gambia, 18 children in Uzbekistan, and a few others in Cameroon, Liberia, Marshall Islands and Micronesia in the past year have something in common – contaminated cough syrups manufactured in India.

The sequence of events that follows each such episode is now familiar – denial by Indian government agencies, setting up of a “review” committee, a few inspections here and there, allegations of conspiracy to tarnish India’s image as the “pharmacy of the world” and occasional “stern warning” to the industry on quality regulations.

This is the context of the latest statement of Mansukh Mandaviya regarding the Good Manufacturing Practices (GMP) to be followed by the pharmaceutical industry.

Mandaviya’s Tough Job

As both the health minister and the minister for pharmaceuticals, Mandaviya has a tough job at hand. This explains why he speaks in two tongues. As the minister for chemicals and fertilisers, he is supposed to promote the pharmaceutical industry and prevent any threats to pharma exports and India’s image as “the pharmacy of the world”.

And, in his role as the health minister, he is in the role of a regulator and is supposed to protect the interest of the public. How does he deal with incidents of Indian pharma products causing deaths and injury due to contamination or poor quality? Should he protect industry interests or should he be on the side of people’s health? He is doing both.

On July 11, Mandaviya, while speaking to industry representatives, talked about being “alert to the quality of drugs” and “expeditiously moving towards GMP through self-regulation”. He elaborated: “Our global position in the pharmaceutical sector is created through the quality of our products. We must undertake all possible steps to ensure that we strengthen this position in terms of value and quality. Hence, the role of self-regulation becomes critical.”

Concession Dressed As Warning

Any talk of “self-regulation” in the pharmaceutical sector undermines the role and mandate of the Drug Controller General of India (DCGI) who is legally bound to regulate the drug industry under the laws laid down by Parliament. In the same meeting, Mandaviya assured the industry of reducing the “compliance burden”.

If India’s health minister thinks compliance with the national drug regulation is a burden, then we need to get worried. But then, he was speaking to the industry as the minister in charge of promoting the pharmaceutical sector. His latest statement, however, comes from the health ministry.

Here he is talking about “warning” and “stern action against defaulters”. He says pharma companies will have to implement GMP compulsorily within 12 months. This too is perplexing because GMP has been mandatory since 2005. In effect, the minister is not giving any “warning” to the industry but offering a concession in the form of time to comply with regulation which it should have done long ago.

Industry’s Challenges

GMP has been a weak point of the Indian industry from the time it was made mandatory in 2005. It is an elaborate set of procedures – contained in Schedule M of the regulatory law -  covering every part of the manufacturing process.

These straddle quality management, personnel, premises and equipment, documentation and records, sanitation and hygiene, raw materials (ensuring that all raw materials used in the manufacturing process are of the appropriate quality and sourced from approved suppliers), manufacturing process, packaging and labelling, comprehensive quality control system, storage and distribution, product complaints and recalls, self-Inspection and audits.

There are specific provisions to prevent contamination and mixing-up of chemicals – the kind of mixing with harmful chemicals that made some batches of cough syrups toxic in recent cases. The objective of GMP is to ensure the quality, safety, and efficacy of pharmaceutical products.

To be fair, the GMP norms are tough and need substantial investments by the industry. Given the structure of the pharma industry – 80 percent of companies are MSME – it is a tall order to implement GMP. Even large companies, at times, falter with GMP as is often found in inspections of their manufacturing facilities done by the US FDA in India.

Political Will

The government has been lenient with compliance and has been nudging the industry to comply with GMP for the past two decades. Previous governments even offered incentives like the ‘Credit Linked Capital Subsidy Scheme’ to the industry to help it implement GMP.

The industry strategy is to keep lobbying for more time for GMP compliance and dilution of specific clauses in it, and it has succeeded once again. It has got one more year from Mandaviya.

Making drug regulation a science-based, efficient, robust and transparent system needs political will. The system should be rid of all vested interests and lobbies. Its goal should be the health and well-being of people in India and wherever Indian drugs are exported to, and not industry promotion. India is yet to get this priority right.

Dinesh C Sharma is a science journalist and author based in New Delhi. Views are personal, and do not represent the stance of this publication.