Explained: What is GMP and why has its absence in the new Drugs, Medical Devices and Cosmetic bill sparked a debate?

The Union Health Ministry recently published a new draft bill to replace the antiquated Drugs and Cosmetics Act of 1940. This draft has sparked a debate as critics say that the government has not just failed to address the issues related to the good manufacturing practices (GMP) in the pharma industry but also not mentioned anything about it in the bill.

The World Health Organization (WHO) defines GMPs as a compliance mechanism for ensuring that products are consistently produced and controlled according to quality standards. It is designed to mitigate the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

It also enumerates risks such as unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

In 1988, India incorporated the system of GMPs via the rules framed by the government, instead of the Parliament. The GMPs were not made the centrepiece of the government's regulatory mechanism. When compared to the United States, the focus is on the GMPs to ensure the manufacturing units produce drugs according to the quality standards.

According to American law, any drug produced in a manufacturing facility, that fails to comply with the GMPs is considered 'adulterated'. It has also made the publication of reports of investigation compulsory for the instigating officer. On the other hand, Indian law did not contain any such criminal penalties.

“At the most, licences may be cancelled, but since the inspection reports are never published, citizens have no idea if the drug inspectors are conducting GMP compliance-related inspections”, said Dinesh Thakur, the whistleblower in the Ranbaxy case, and Prashant Reddy T, a lawyer, in their article titled ‘A new legislation that mirrors the old’.

They also added that there is ample evidence to suggest that the investigations were not carried out and the newly drafted bill does nothing to change this system.

One of the biggest problems that have plagued the Indian pharmaceutical industry is the increase in the number of drugs found that is not of standard quality (NSQ).

On February 3, 2017, while answering a question in the Lok Sabha, the Minister of State of the Health and Family Welfare Ministry spoke about the number of NSQ drugs found in an extensive nationwide survey conducted from 2014 to 2016, which assessed the extent of NSQ/spurious drugs in the market by testing 47,954 randomly drawn samples. The result showed that 0.0245 percent were spurious and nearly 3.16 percent were NSQ.

A research paper titled ‘Drug regulation in India: The working performance of CDSCO and SRDAs’ (September 2019) by Shree Agnihotri and Sumati Chandrashekaran mentioned, “As per data from RTI responses, approximately 7 in every 100 drug samples are found NSQ in Uttarakhand and Odisha”.

A report released by the Authentication Solution Providers’ Association (ASPA) (an organisation working against fake medical products) in 2022 showed that during the COVID-19 pandemic, incidents of substandard and falsified (SF) medical products increased by almost 47 percent from 2020 to 2021. Products included vaccines, medicines, test kits, antibiotics, face masks and sanitisers.

In the earlier Act, the Indian GMP system did not mention several points like considering products adulterated if the GMP was not followed, separate GMP for biological products, the definition of investigational drugs, and the inclusion of experimented drugs in GMP, etc.

It also left terms such as ‘component’, ‘non-fibre’, ‘fibre’, ‘Quality Control Unit’, ‘in process material’, ‘acceptance criteria’, ‘medical feed’, ‘medical premix’, ‘representative sample’ and many others undefined.

According to FDA documents, non-compliance with GMP norms could attract stringent regulatory actions, whereas, in India, similar action would not have been classified as ‘adulterated’. In the worst-case scenario, the licence of the company could be cancelled.