Generic drugs vital for affordable healthcare

KK Talwar

Former Director, PGIMER

INDIA is referred to as the pharmacy of the world. A large number of generic drugs are exported from India across the globe. Until the early 21st century, the patent regime in the country permitted only process patents and not product patents. This presented an opportunity to the Indian pharmaceutical industry to manufacture drugs without risking patent violation. With reverse engineering, different manufacturing processes could be evolved. India’s pharmaceutical sector is counted as one of the success stories of Indian manufacturing. We are the biggest supplier of generic drugs to the world, particularly in critical areas such as HIV/AIDS and life-saving vaccines. Generic drugs are medications with the same active ingredient as ‘branded’ drugs and, therefore, with similar benefits.

A major reason for advocating generic drugs is their low cost as they don’t have to go through repeated animal and clinical studies. Because of the cost issue, they are vital for developing nations and have, of course, tremendously benefited the world. It goes without saying that no compromise on quality is acceptable when it comes to medicines. There is a genuine perception in society that some of the generic drugs available in the country are substandard. Owing to these concerns, patients are justifiably reluctant to use generic drugs and often prefer branded medications in spite of their high cost. This is demonstrated by poor sales at Jan Aushadhi outlets.

The recent notification of the National Medical Commission (NMC) to the effect that doctors should prescribe only generic drugs was well-intentioned. But it brought to the fore the serious issue of the quality of available generic drugs. Doctors expressed legitimate concerns, which were highlighted by the media. The NMC rightly put its decision regarding mandatory prescription of generic drugs on hold. Nevertheless, the focus on the importance of generic drugs is timely. Indeed, the use of generic drugs is the way to reduce out-of-pocket expenditure on healthcare and the government should make all-out efforts to ensure quality generics.

Spurious or substandard drugs in our country are mainly a result of a weak regulatory ecosystem. Instances of serious complications following the use of some such preparations have been reported. Last year, the PGIMER, Chandigarh, observed adverse outcomes, even death, from the use of propofol manufactured by a company. The deaths in the Gambia, linked to the use of a cough syrup exported from India, sullied our nation’s reputation as a pharma hub. The attendant risks with substandard drugs, such as inadequate response and even the development of drug resistance, are issues of serious concern. In the absence of an effective regulatory mechanism, some drug manufactures cut corners and avoid following internationally accepted best practices. More often than not, complacence and negligence, if not outright dishonest practices such as adulteration, are observed. Spurious drugs (whether contaminated or substandard) usually result from negligence or deliberate wrongdoing during the manufacturing process. This is completely unacceptable and must be condemned in the strongest terms.

It is well known that European countries and the US approve generic drugs for use only after due validation that the drug is as effective and safe as a branded drug and can be its substitute. A rigorous review process is in place for the approval of any generic drug. America’s Food and Drug Administration (FDA), for instance, even inspects manufacturing plants to ensure compliance with manufacturing best practices. This translates into increased patient confidence in generic drugs. The numbers speak for themselves — according to the IMS Health Institute, generic drugs saved the healthcare system in America nearly $2.2 trillion in a decade (2009-2019).

Thus, we need to learn lessons and take steps to strengthen our regulatory mechanism. Unless strict quality control measures are in place, and compliance with quality standards is assured, the twin threats of ineffective medication and serious side-effects will remain. There is an urgent need to have a relook at our extant policy guidelines and bolster the enforcement process. Adequate infrastructure in the form of testing facilities manned by fully trained professionals must be ensured. Strict monitoring of the existing statutory and other safeguards is vital. The legal and regulatory regime should be so structured as to encourage voluntary compliance and self-regulation, while possessing the teeth and the will to deal with deviant cases with a heavy hand. The Central Drugs Standard Control Organisation (CDSCO), the Indian authority responsible for regulating the quality of drugs, must be strengthened and empowered.

There is also a need to strengthen our drug alert and pharmacovigilance programmes. These are ways to ensure the safety of our products post-marketing. Any further action following such drug alerts resulting in a recall of the drugs must be put in the public domain at the earliest.

Once quality generics are available, the government should instruct pharmaceutical houses to not even market branded drugs. Pharmaceutical companies should be encouraged to cut their marketing budgets and spend more on research and development as well as on quality control.

The CDSCO must rise to the challenge to ensure quality generics. Once we put our house in order, the mandate of the NMC will be welcome.

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