The Prime Minister’s push for a law which mandates doctors to prescribe medicines with generic names rather than brands hasn’t gone down well with a vast majority of doctors. A study which surveyed doctors across India shows that an overwhelming 73% oppose the decision. Their main concerns were regarding the quality of the drugs available.

The results of the survey were carried in the Times of India. It says that the decisions seems to lack a well thought-out plan and also could affect patient health. As per the survey, it’s important for the government to consider the quality of the generics and also the qualification of the decision-maker who dispenses the drug at pharmacies.

The concept of writing prescriptions in generic names is based on the premise that unbranded generics are cheaper compared to their branded counterparts.

Response similar from cities of different tiers

The doctors expressed disagreement with the government’s recommendations- a response that was more or less uniform across tier-1, tier-2 and tier-3 cities.

It’s not that doctors don’t find the idea of providing cheap medicines repulsive. On the contrary. But the lack of standardization of generic drugs is a cause of concern. The concerns of healthcare professionals range from the generics’ quality to how qualified the chemist at the retail pharmacy would be.

The healthcare professionals feel that the quality of the medicines that eventually reach the patient would depend on the pharmacist and what he wished to sell without even knowing the medicine’s effect. This could “severely affect patients’ health.” Empowering chemists could also push up prices since they could sell brands that give them higher absolute margins, the healthcare practitioners say.

As per Dr Anoop Misra, the chairman of Delhi-based Fortis CDOC)(Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology), “Generic medicines are excellent low-cost options, provided pharmacological properties of these medicines are standard and quality-controlled, and that all good manufacturing practices are followed according to international norms. Unfortunately, this is not the case for many medicines (even branded) in India mostly due to lack of stringent quality control measures and absence of punitive actions for faulty manufacturing standards.”

Are all generics in India made equal?

A crucial question the government needs to ask at this point is whether all generic medicines in the sub-continent are of the same quality. In both the EU and the US, the authorities have ensured that generic drugs are therapeutically equal to innovator drug. This is possible because bioequivalence(BE) testing is mandatory in those places.

What this means is that generic formulations get tested on healthy volunteers. Such BE studies are not just cost-effective, they also carry very little risk as opposed to clinical trials that the company conducted for approval of the innovator product.

If bioequivalence can be established, a generic drug would get certified as having the same quality. This legal stamping means that it could then be interchanged for the innovator product.

Until a couple of months ago, India mandated such studies only for formulations which seek approval within four years since the innovator product got approved. This meant that most generic drug makers sought approval from the fifth year onwards. BE studies were thus evaded. But on April 3, the law came to effect that makes BE testing of all highly soluble drugs mandatory.

That’s certainly a good, albeit belated move. But how good are the generics approved before April 3?

The simple answer is, nobody can be sure. And in the absence of proof of BE, is it ethical for doctors to be forced to make the choice? The answer should be obvious- a resounding no. However, the government doesn’t seem to consider this.

Before making prescribing generics mandatory, the government should have a legal mechanism in place to ensure that all generic are bioequivalent to the innovator products.

But that’s just one side of the coin. For even with successful BE studies, a drug could fail for multiple reasons- like heat and humidity that could cause lack of stability. And such problems could be especially huge in government-run hospitals.

In other words, the government’s push for generic drugs certainly doesn’t seem to be well thought-through.

Image credits: timesofindia.indiatimes.com

   Send article as PDF