Experts oppose govt plan to bring law on generic drugs

FILES-US-HEALTH-DRUGS-CHILDREN In India, almost all the drugs produced are generic drugs sold under different brand names | AFP

“Physicians should be free to use their clinical experience in choosing what to prescribe”

In his bid to make healthcare affordable, Prime Minister Narendra Modi announced on Monday that the government would bring in a legal framework to ensure that doctors prescribe low cost generic drugs. But many feel such a legislation is not required. Dr K.K. Aggarwal, president of the Indian Medical Association told THE WEEK that “no new legislation” was required since the Medical Council of India's (MCI) code of ethics already prescribes such an "etiquette".

According to the MCI, “every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there's a rational prescription and use of drugs”. Aggarwal explains that “generic name” means the “original salt name of the compound”, and is not the same as generic drugs. For example, aspirin is the generic name for the chemical acetyl salicylic acid.

A drug can be sold under any of the three categories: under the name of the salt, unpopular brand name and a popular brand name. Aggarwal says that the same company usually sells them under all three categories—under the salt name they sell in a supply of 100 or more; under unpopular brand name they pitch for an institutional bulk supply, and under popular brand name they market for individual doctors' prescription. The cheapest, he says, is of course, the generic salt. 

In India, however, almost all of the drugs produced are generic drugs sold under different brand names. The prices of these may vary, and are not controlled by doctors. Instead, the MRP is fixed and permitted by the government.

So why do physicians prefer branded drugs instead of generics? Quality and availability, many doctors say. “The first step is for the government to ensure quality of our drug supply. As the Indian Pharmaceutical Association itself said [in an article], 85% of what is sold in India has never been proven to work therapeutically. We need to first fix this problem,” says Dinesh Thakur, public health activist and chairman of Medassure Global Compliance Corporation.

The reason physicians prefer branded drugs is because the clinical practice shows that most generic drugs don't work, says Thakur. “They don't make patients feel better. Therefore, based on their experience, they gravitate toward using branded drugs. I don't condone any of the excesses in promoting medicines; there are a number of cases of pharma companies promoting products which are no better than their generic equivalents. That must be stopped. But the way to do that is not for us to become a nanny state, where the government babysits us. Physicians should be free to use their clinical experience in choosing what to prescribe, not be restricted by the government in choosing one formulation over another,” he says. 

On the subject of quality, Aggarwal says that doctors' concerns over spurious and substandard drugs are yet to be addressed. “The government employs only about 1,800 drug inspectors for the entire country. This is grossly inadequate,” he says, adding that the government itself admits that “less than 0.01 percent” of the drugs produced in the country are tested for quality. “It will not be fair on the part of the government to expect doctors to prescribe substandard drugs,” he says, arguing for strict implementation of existing laws instead. The IMA supports the move to write the generic name of the drug alone, but doctors need to mention the name of the company of whose generic the patient should buy, and that should be available easily, says Aggarwal.

To address the quality issue, Thakur says that existing regulations must be brought on par with globally acceptable standards, qualified people should be employed to enforce the regulations and those who make substandard drugs should be held accountable. “In parallel, bring transparency in the promotion processes. There are some things that the industry does which are clearly unethical. They must be stopped,” he says. 

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Topics : #Healthcare

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