In search of consistent quality

Global regulators question perfection, look for the right approach to quality and to understand how a company responds to issues flagged during inspections

The theme for the Indian Pharmaceutical Alliance’s flagship event, the Global Pharmaceutical Quality Summit, was Patient Centricity and the Future of Manufacturing and Quality. A pertinent choice, given the reverberations from children’s deaths across at least seven countries, which have been linked to Made-in-India cough syrups and other formulations. The comments of global regulators at the IPA Summit are additionally significant when viewed against this tragic backdrop.

Big India pharma finds itself on the back foot, thanks to such recurring incidences. Speaking during the inaugural session, Nilesh Gupta – Chair, Quality Forum, IPA and MD, Lupin asserted that “the priority is to deliver a quality product, consistently.” His comment that “capability building within the India pharma sector is key to play its role in the transformation of India into a developed nation” reflects the stark reality of the wide variation in quality standards of medicines within the country.

S Aparna, Secretary, Department of Pharmaceuticals, Government of India, in her keynote address during the inaugural session, referred to another widely accepted variation: India’s vast geography and federal structure translates into multiple levels of drug regulation, with varying degrees of capabilities, requiring continuous capacity building measures within the regulatory body itself.

But her hopes that the IPA Summit would motivate more MSMEs to seek the schemes launched by the government to help them upgrade their quality systems needs to be emphasised beyond IPA’s membership of the 20-odd big Indian pharma companies.

Fortunately, IPA Secretary General Sudarshan Jain revealed that IPA’s quality workshops have now been opened to non-member companies as well. That’s certainly a good move. The cases highlighted in Gambia and then across more countries, prove that medicine quality can no longer be treated as a competitive advantage, with best practices being marked ‘For Members-Only”.

The Secretary, DoP’s message was reiterated by Rubina Bose, Deputy Drugs Controller India, CDSCO during a panel discussion with representatives of three global regulators: Sarah McMullen, Country Director, India Office, Office of Global Operations, USFDA; James Pound, Deputy Director Standards and Compliance, MHRA and Thomas Hecker, Inspector, Certification of Substances Department, EDQM.

Despite the negative connotations of import alerts and post-inspection observations, the global regulators on the dais seemed to call for a more holistic view of inspections. For instance, McMullen said that the “US FDA does not expect perfection”, reasoning that while problems do occur, what counts is how companies handle these identified issues. This was echoed by the EDQM’s Decker who said it was more important to understand how a company responds to issues flagged during inspections.

When moderator Shirish Belapure, Senior Technical Advisor, IPA joked that pharma heads in India were cancelling vacation time, thanks to the multiple inspections being conducted at pharma plants, Decker wondered why that was so. His reasoning that once good (quality management) systems were in place, teams would manage inspections even in their seniors’ absence triggered a wave of uneasy chuckles from the audience. The reaction exposed a crucial fault line: just how much do written SOPs reflect actual practice?

Regulators are plugging loopholes and tightening laws to safeguard patients. For instance, the US FDA issued a guidance in May 2023, alerting pharma manufacturers, to the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG).

It is well known that both contaminants enter the pharma supply chain, either due to negligence or willful mixing of pharma-grade glycerine with its industry-grade equivalent. Scant or faulty analytical methods do not catch the contamination. The contamination or mixing of both grades of solvents is most likely deliberate, as there is a vast price difference between the two grades. It is difficult to trace back such ‘contaminated’ solvents to rogue traders, as there are multiple selling points and smaller pharma companies do not document all such purchases.

Over the past few months, India’s drug regulator CDSCO has also upped its game. Reports suggest that 209 pharma manufacturing sites, known for previous GMP violations, have been jointly inspected by both central and state drug inspectors. 71 companies have been reportedly issued show-cause notices, and 18 companies have been asked to shut down.

In addition, in May, CDSCO mandated that all cough syrups due for exports would need to be checked at Central/ State Drug Testing Laboratories. This has however created a backlog of cough syrup samples at certain labs. On June 13, CDSCO announced that it would update the number of batches of cough syrups it receives at each of its labs so that companies send their samples to labs with fewer samples.

However, these steps do not seem to be enough. Putting a question mark on the test reports from government-controlled labs, Gambia’s Medicines Control Agency mandated that from July 1, all medicines exported from India to Gambia would first need to be tested at a designated private lab in Mumbai. The detailed pre-shipment document verification, physical inspection, quality control testing and issuance of Clean Report of Inspection and Analysis for pharma products now mandated by Gambia will probably delay exports and add to the costs. Will other countries follow suit and risk medicine shortages?

The IPA Summit ended with the Union Health Minister Dr Mansukh Mandaviya’s assertion that ‘the Government has a zero-tolerance policy against those who compromise with the quality of the medicines.” He also urged the industry to establish a self-regulatory body to maintain the quality of the pharma products. Is this an attempt to shift responsibility to pharma associations, even though this strategy has not worked as well as it could so far? Clearly, both the regulator and the regulated need to move faster to salvage lost reputation.

CDSCOdiethylene glycolethylene glycolIPA SummitMade-in-India cough syrupspharma supply chainUS FDA
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