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.
“In a country like India, where public health is the least of the government’s concern, especially when it comes to drugs, dietary supplements and alternative medicine, it is up to public health activists and clinical scientists like me to make these data transparent and realistic for people to be well-informed on,” said the doctor.
The idea, he added, is to ring the alarm bells so that drug regulators take the issue of quality control more seriously.
ThePrint tried reaching Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), who heads the CDSCO, for his comments on the allegations and the planned initiative over the phone but calls went unanswered.
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Project going bigger
The types of drugs that MESH plans to test include generics supplied by the Kerala government and the central governments (from Jan Aushadhi Kendras), branded generics, and original branded drugs.
The drugs to be tested include Paracetamol (antipyretic), Azithromycin and Amoxicillin (antibiotic), Ranitidine and Pantoprazole (antacid), Metformin (anti-diabetes), Atorvastatin (used for treating high cholesterol), and Atenolol, Telmisartan and Amlodipine (for treating hypertension).
“We have the expertise to carry this forward and require only lab services to make it happen,” Philips said. “Of course, we need crowdfunding support to go ahead with the initiative and, depending on the public response and results, this may be an ongoing project.”
Public health expert and senior MESH member Dr Nandakumar said generic medicines should “ideally be the way to go because they are cheaper and bring down the cost of healthcare significantly”.
“But in the absence of an effective regulatory mechanism, the generics made by the majority of small and medium drugmakers, on many occasions, are not up to mark,” he added.
‘Need nuanced approach’
A pharmaceutical expert who did not wish to be named said while the initiative sounds novel, the sampling for exercises like this needs to be done in a scientific manner.
“For example, if a drug from a certain batch turns out to be NSQ, this does not mean drugs from all other batches by the company would be the same,” he said. “One has to remember that the concept of proof in medicine is complicated.”
He also pointed to the results of the largest-ever drug quality survey — National Drug Survey 2014-16 — commissioned by the Union Health and Family Welfare Ministry, whose results were declared in 2017.
The survey showed that, out of the 47,012 samples tested, 13 were found to be spurious and 1,850, NSQ.
“All the samples were subjected to test/analysis as per pharmacopoeial requirements in the central and state drug testing laboratories that have been accredited by National Accreditation Board for Laboratories,” the Centre had said in a press statement.
“As such, the percentage of NSQ drugs in India has been found to be 3.16 percent and that of spurious drugs, 0.0245 percent”.
However, the NMC’s Registered Medical Practitioner (Professional Conduct) Regulations, 2023, last month — which mandated prescribing of generics but was later put on hold on the directions of the government — were opposed by the Indian Medical Association, the largest network of doctors in India, on the grounds of lack of quality assurance.
“India’s drug ecosystem is simply not ready for it,” IMA general secretary Dr Anil Nayak had earlier told ThePrint.
This report has been updated with additional information
(Edited by Sunanda Ranjan)
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