Doctors wary as Centre pushes for generic drugs

Several practitioners say medicines made without strict quality checks could affect patients, urge caution

April 26, 2017 10:00 pm | Updated April 27, 2017 12:32 am IST - Bengaluru

Stringent quality checks of generic drugs are missing in India, say some doctors. File

Stringent quality checks of generic drugs are missing in India, say some doctors. File

Following the Centre’s advisory to physicians to prescribe drugs with generic names, doctors across the country are worried that any change in drug — especially for patients with chronic illnesses and critical care — may risk patients not getting the full benefit of a particular drug.

A section of doctors argue there is no concrete evidence to show that generic drugs are equal to branded drugs, with respect to bioavailability, potency, efficacy and impurity content. There can be complications and some of the ailments and diseases can go out of control, they argue. Besides, some of the branded drugs are available at a lower cost than generic drugs as they have been price capped under the National List of Essential Medicines (NLEM).

“There are serious concerns and several organisations, including the Indian Epilepsy Association, the Indian Academy of Neurology and the Movement Disorder Society of India will soon write to the Centre raising the concerns,” said G.T. Subhas, president of the Indian Epilepsy Association. They will soon meet and come out with a common representation to be submitted to the ministry.

Pointing out that the bioavailability of a generic drug molecule is not assured by quality control or clinical trials, C.N. Manjunath, Director of the State-run Sri Jayadeva Institute of Cardiovascular Sciences, said the very fact that the same company manufacturing a branded drug also manufactures a generic drug means that there is a shift in quality. He said one should not compromise on quality of drugs, particularly in critical care sector, including cardiac emergencies.

A senior doctor of neurology from the All India Institute of Medical Sciences said while the concept of reducing the cost is welcome, stringent quality checks of generic drugs are missing in India.

“Anywhere else in the world, generics undergo scrutiny and a particular drug is manufactured by a single company. Here, tens of companies manufacture the same drug and the final call will be taken by the chemist, who will use the opportunity of selling the drug for which he gets the highest margin,” said the doctor.

Terming generic drugs as “illegal” going by the U.S. laws, Gagandeep Singh, Secretary of the Indian Academy of Neurology, said companies manufacturing generics see the composition of a particular drug and manufacture them without any research and clinical trials. “It is a reverse process and there is no quality check,” he said.

The doctors question who will be held responsible if any generic medicine has an adverse affect on the patient. “Will the government or pharma companies take responsibility,” asked Dr. Manjunath.

The Indian Medical Association (IMA), while welcoming the push for generic drugs, insists that it is “discretionary and non-mandatory”.

IMA National President K.K. Aggarwal told The Hindu that the concern of the medical profession regarding spurious and substandard drugs is yet to be addressed and more such drugs might get into the market under the guise of generic drugs. “The government has only around 1,800 drug inspectors for the entire country, which is grossly inadequate. Indiscriminate dispensing of antibiotics and other prescription drugs by doctors not qualified in modern medicine, quacks, and by Over The Counter Sales has led to emergence of serious resistant micro-organisms. Strict implementation of the existing laws should suffice in this regard,” he said. “The government itself admits that less than 0.01% 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 said.

“The IMA is for promotion of drugs in the NLEM so that all drugs are price capped and cheaper. While writing the generic name of the drug, we also need to mention the name of the company of whose generic the patient is going to buy. The answer therefore is write the generic name of the drug, choose from NLEM, write Jan Aushadhi, or a standard company name,” he added.

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