New Delhi : The National Medical Commission (NMC) may have put on hold a controversial order asking doctors to prescribe only generics or face penalty, but the intense debate the development triggered has led a group of doctors and scientists from Kerala to start a first-of-its-kind project to assess the quality of generics in India.
At the forefront of the initiative is Dr Cyriac Abby Philips, a hepatologist-clinical researcher from Kerala, known on social media for his critical views of ayurveda and other forms of traditional medicine.
As part of the initiative, Dr Philips and other members of a group called ‘Mission for Ethics and Science in Healthcare’ — which is a network of biomedical experts, mathematicians, clinical researchers and lawyers apart from doctors and scientists — have decided to test 10 categories of generics and branded generics.
These include commonly used medicines such as those for treating fever, diabetes, high cholesterol and hypertension.
Speaking to ThePrint, Philips said the idea behind the initiative came when he randomly tested four medicines — generics and branded generic versions of Metformin and Atorvastatin, used in treating diabetes and high cholesterol — in a private laboratory at Cochin.
“One of the house helps in our building had been taking generic medicines given to her by a state-run hospital for these conditions for the last three-four months and was not showing any improvement,” he said.
“After the patient was transitioned to the branded versions of the medicines, her symptoms improved, so I decided to get these four medicines tested in a drug-testing laboratory using money from my own pocket,” he added.
The results, seen by ThePrint, showed that while Atorvastatin manufactured by Mumbai-based generic drug-maker Anchor Pharma (as An-Vastatin), failed the assay test — which tests whether the amount of molecule present in a drug as specified on the label meets Indian Pharmacopoeia standards — all the other medicines cleared it.
The generic drug that failed the assay test — An-Vastatin 10 (batch number C 5497/23) — was declared ‘Not of Standard Quality (NSQ)’ by the laboratory.
Philips said An-Vastatin is supplied as part of an arrangement between the state government and the drugmaker, and is not available at any shops or online to buy outside state-run hospitals.
ThePrint has reached Anchor Pharma by email for a comment, but no response had been received by the time of publishing this report.
“When one out of four medicines tested has failed this crucial test, it is evident that the problem is very widespread and that’s why we want to expand the project,” Dr Philips said.
“But since the cost of testing a large number of drugs would be far higher — it will be a public-funded initiative,” he added.
Philips, however, noted that since a sufficient number of generic medicines of the same batch could not be retrieved from the patient, he could not get two other efficacy tests performed — disintegration (showing time taken by a drug to disintegrate in stomach) and dissolution (extent and rate of solution formation from a dosage form).
“These tests can actually tell the bioavailability of a drug (the extent and rate at which the active molecule enters systemic circulation, thereby accessing the site of action),” the clinician-researcher said.
Even though the Central Drugs Standard Control Organisation (CDSCO) and state drug controllers carry out random quality checks on drugs in the market, people and even doctors are not privy to the results, he said.
“But since the cost of testing a large number of drugs would be far higher — it will be a public-funded initiative,” he added.
Philips, however, noted that since a sufficient number of generic medicines of the same batch could not be retrieved from the patient, he could not get two other efficacy tests performed — disintegration (showing time taken by a drug to disintegrate in stomach) and dissolution (extent and rate of solution formation from a dosage form).
“These tests can actually tell the bioavailability of a drug (the extent and rate at which the active molecule enters systemic circulation, thereby accessing the site of action),” the clinician-researcher said.
Even though the Central Drugs Standard Control Organisation (CDSCO) and state drug controllers carry out random quality checks on drugs in the market, people and even doctors are not privy to the results, he said.
