A step in the right direction?

The Ministry of Health and Family Welfare recently amended a law to make bioequivalence studies compulsory for certain classes of generic drugs manufactured in India. The Drugs and Cosmetics Rules, 2017, was formally amended through a notification on April 3 to incorporate this change. Bioequivalence studies are conducted to indicate that two medicines, the original patented drug and a generic version, have the same biological equivalence.

This means that they should work in the same way and towards the same purpose. Although the new law makes bioequivalence mandatory, it is often waived off for highly water soluble drugs. This is because these drugs are considered to be more easily absorbed by the body.

If one were to understand why these amendments are significant, it is important to know the history of modern drug regulation, particularly with reference to generic medicines. In the 1960s, the United States amended its law to require drug manufacturers to demonstrate proof of the efficacy of their new drugs.

This meant conducting extensive clinical trials, which required many patients and costs that sometimes ran into hundreds of millions of dollars. This cost also created an entry barrier for many competitors once the original drug expired.

Further, the US introduced another act which enabled competitors to introduce generic versions of the proprietary drugs, minus repetitive clinical trials. However, the requirement to conduct bioequivalence tests for generic drugs remained. Bioequivalence studies establish whether the generic drug would dissolve at the same rate into the bloodstream as the patented drug.

Bioequivalence studies are conducted on a smaller group of people thereby making them more cost effective and less time consuming than full-fledged clinical trials. The cost of generic drugs is lower due to the same reason.

In India, so far, under the Drugs & Cosmetics Rules, 1945, only those generics that are approved by the Drug Controller General of India within the first four years of the innovator drug being approved in India undergo bioequivalence studies. Generic drugs that come into the market after those four years need to take permission only from the state licensing authorities.

The fact that state licensing authorities did not ask for data on the performance of drugs approved by them jeopardised public health in a major way. This is one reason why doctors were prescribing generic drugs without any data on their performance. Many domestic manufacturers used this opportunity to wait till the fifth year to get approval and start selling their generic products.

The Indian scenario

This amendment has come at a time when the Medical Council of India has re-instructed doctors to prescribe drugs with generic names. It is also likely to increase costs for pharmaceutical companies. Before this amendment, the Indian regulatory framework had a serious shortcoming, which put drug safety in question.

The amendment, therefore, is definitely a step in the right direction. It will align the Indian scenario with the global standards and also ensure that the generic drugs are safe and effective.

Another thing to consider here would be self-certification of drugs by companies to indicate whether they are bioequivalent. For instance, there could be some indication on the packaging of the drug which tells that it has been tested for proof of bioequivalence. An indication of the trial ID number could also be made mandatory.

Periodic testing of samples drawn from pharmacies generates three data sets, which ideally should be made available publicly. First is the laboratory test report, second is the investigation report by drug inspectors on drugs that have failed the test and third is the criminal complaint filed in court against the manufacturer along with the final court judgement. If this information is made available online, it will help empower hospital procurement officers, pharmacists and patients with the information required to avoid those products which have a poor quality record.

While the move on conducting bioequivalence tests for drugs is commendable, it is also a fact that the judgement to choose a rational drug and its format vests only with the registered medical practitioners. This right of the medical profession is sacrosanct. As per a study, there is no evidence that brand name drugs worked any better than generic drugs. And therefore, differential pricing can be done away with and a uniform policy should be adopted for all categories of drugs.

The cornerstone for a vibrant public health framework is access to affordable and safe medicines. Future challenges may include ensuring that clinical research organisations conducting bioequivalence studies do not commit fraud.

(The writer is president of the Indian Medical Association)