National Medical Commission, a government regulatory body whose guidelines have to be followed by all practising doctors in hospitals, has issued a guideline that the doctors have to prescribe only generic drugs and not branded drugs.
This has not gone well with the doctors across the country and more so with the doctors in Visakhapatnam. They feel that by doing so, they will be compromising on the quality of treatment of the patients.
But to understand the issue one has to first understand the difference between patented drugs or branded generic and generic drugs. Only then can we explain why we insist that the guideline should be removed, said former Principal of Andhra Medical College and former Assistant Director of Medical Education, AP, P.V. Sudhakar.
Patented drugs
In normal circumstances, a pharmaceutical company comes out with a new drug after spending crores of rupees on research and testing, which at times takes years. They then go for a patent, and as per the norms they are the only ones who can sell the drugs of a fixed period of about 20 years. This leverage is given so that they can get the cost that they had invested in research, testing and manufacture of the drugs.
After the fixed period, the formulae is given to other companies and they can manufacture and sell in the market and this is called generic drugs. They can sell the generic drug with a brand name or just sell it with the approved chemical name. If they sell under the brand name then they become branded generic and if they sell by the chemical name such as Paracetamol, then they become just generic drugs, said Dr. Sudhakar.
The former are called branded generics (as Calpol) and the latter are called just Generics (as Paracetamol).
A few senior doctors in King George Hospital (KGH), Visakhapatnam, say that any company wanting to market a generic drug does not have to undergo trials to show that the drug is effective, since the patented company has already done it.
All they have to do is provide evidence that their drug is similar to the patented drug in all characteristics such as chemical content, its bioavailability and a few other parameters, which is called bioequivalence, said Dr. Sudhakar.
Thereafter, the generic company gets the licence to sell the drug in the market. This licence is issued by the regulatory bodies such as the FDA in the USA or EU in Europe and DCGI in India. All these regulators insist on bioequivalence studies only, he said.
But as per Mr. Sudhakar and doctors in KGH, The problem is that the Indian regulators (unlike regulators in rest of the world) do not require bioequivalence studies to be done before awarding licence to the companies to sell the drug. In fact, Indian authorities do not even have their own laboratory for such complex studies, especially for biological complex medicines.
“So essentially we have no way of knowing whether the drug being marketed in India has the same quantity, quality, impurities etc. when compared to the patented drug. We have to just rely on the Indian Pharma company’s word (with no data) that the generic drug that they are selling is as good as the original patented drug,” said Dr. Sudhakar.
However, the doctors do understand the reason why the NMC has been insisting on generic. Primarily, the generics come much cheaper, at times even 50 to 70% cheaper than the patented or branded and drastically reduce the health cost and make treatment available to all at a cheaper price, but quality can be compromised, they say.
The guideline should not be binding, it should be left to the discretion of the doctor, said Dr. Sudhakar.
