Generic meds debate heats up

In the backdrop of a regulation on mandatory prescribing of generic medicines, doctors anticipate unethical practices to crop up in drug sales. With no strong quality regulation system in India, doctors foresee a nexus between pharmacists and drug manufacturing companies.

“Generic medicines are excellent low-cost options, provided pharmacological properties of these medicines are standard and quality-controlled, and that all Good Manufacturing Practices (GMP) are followed. Unfortunately, this is not the case for many medicines, including branded ones in India; mostly due to lack of stringent quality control measures and absence of punitive actions for faults,” said Anoop Misra, Chairman, Fortis-C-DOC Centre for Diabetes, Metabolic Diseases and Endocrinology.

“Widespread use of low quality generics can lead to drug resistance, and inability to control diseases (diabetes, hypertension),” he said.

Doctors, however, agree that generic medicines have great potential to serve a huge pool of poor patients, and insist that there is no difference in generic and branded medicines considering the quality. According to doctors, if the authorities want them to prescribe drugs through chemical names, the government should not allow so many brand names and reduce wide price variations, too.

“In India 98 per cent of the medicines are generic, sold under a brand name as there not many patents with big companies manufacturing these medicines,” said Dr Surender Singh, Professor of Pharmacology, All India Institute of Medical Sciences, New Delhi.

“To an extent, branded medicines are assured in quality as they follow the GMP under a license from the government. Generic medicines don’t have medical representatives and not many patients or even doctors know about it. If at all the law comes in force, Medical Council of India (MCI) will push it in government hospitals, but private hospitals will not be affected,” he said.

Quality issues

As per the National Drug Survey released in February 10.02 per cent ‘not of standard quality’ drugs were circulating in government hospitals. Spurious drugs found were 0.059 per cent