Indian generics: Grappling with quality issues

The National Medical Commission (NMC) recently notified guidelines requiring doctors to prescribe generic drugs.

However, these are on hold now as several medical associations expressed serious concerns. Even as these are deferred, there is a need to review a few aspects.

First, although generic medicines are 30-80 per cent cheaper than branded drugs, and prescribing them may help in bringing down healthcare costs, medicines should not be seen only through the prism of price. Medicines in India are already among the most affordable and globally accepted from quality compliance perspectives. But the expenses associated with medical treatments remain a burden for people without insurance coverage, leading them to bear out-of-pocket costs.

The government’s flagship PM-JAY health insurance scheme provides a sum insured of ₹5 lakh per family for secondary and tertiary care.

Quality first

It is important to focus on quality of medicines, branded or generics and these must be prioritised across the 3,000 pharma companies and 10,000-plus manufacturing units. Quality-related challenges must be addressed before going ahead with updated guidelines. The biggest impediment or concern is the possible variation in the quality of plain generics manufactured by very few companies in India.

The primary emphasis should lie on the quality of medicines, guaranteeing complete recovery of patients in accordance with the Standard Treatment Guidelines (STG). The unfortunate incidents in Gambia and Uzbekistan sully the image of the country and our industry. Some MSMEs manufacturing generic medicines need to be educated on quality compliance standards and DCGI is also making efforts in this direction.

The Union Health Minister also stated in Parliament recently on risk-based inspections, that there have been very few global recalls of branded generics produced in India and this is testament of their quality. No doctor would like experiment with plain generic drugs for patients battling life-threatening diseases.

Doctors fear that the NMC suggestions would lead to by pharmacies swapping brands, since medical stores generally do not stock generics because of lower profit margins. If the particular generic version is not available, the responsibility of substitution would shift to pharmacists who may only promote brands that have good profit margins irrespective of quality.

Robust regulation

Plain generic products are often manufactured by companies whose quality is yet to be certified. But branded generics tick all the boxes on parameters such as the source of the API, its form, dosage, good manufacturing practices, packaging, unit price, supply chain SOPs and quality control. Thus, the regulatory system for quality checks can be made more robust for plain generics.

Currently, due to restricted resources and manpower, testing and quality checks occur at irregular intervals, creating a loophole through which sub-standard and counterfeit products infiltrate the supply chain, often with devastating consequences as the incidents in Gambia and Uzbekistan proved. Focusing only on generics can potentially increase the number of incidents of counterfeit medicines.

Trust, efficacy and patient safety are the key factors driving the popularity of branded generics in India.

The primary emphasis should be on implementing more stringent regulatory measures to guarantee the safety of generic medications.

The selection of a medication should not rely solely on the cheapest option, but rather on a quality drug that remains affordable. Most important is to ensure implementation of quality culture system in every pharma company by all stakeholders.

The writer is CEO - QbD International, QbD / CGMP consulting, United Nations Adviser

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