Last week, a doctor interviewed at New Delhi’s All India Institute of Medical Sciences (AIIMS), the country’s premium government hospital, said he always doubted the efficacy of drugs used in surgeries and sourced from the Central government dispensaries.
Last year, an anti-tuberculosis batch of drugs supplied by Nestor Pharmaceuticals Ltd to the Jharkhand government was found to be substandard. But by the time it was discovered, they had already been disbursed to various government agencies. Nestor no longer supplies drugs to any government, but chairman Rahul Sehgal blames business rivals for the allegations even while refuting all charges. And in 2003, part of a drug consignment meant for Municipal Corporation of Delhi-run dispensaries and sold by Unisule Laboratories, was found to be low on therapeutic quality in sample testing initiated by an association of large drug makers. A Unisule executive denies the charge.
India’s sprawling public health-care system—inadequate in scope and scale, yet the only source of hospital services for millions of people—sometimes distributes drugs that are substandard or fake. That doesn’t come as a surprise to experts who say that despite its elaborate nature, the process of drug procurement, quality checks, and distribution is so riddled with gaps that some suppliers of the Rs4,000 crore worth of medicines bought every year by central and state governments find it easy to slip in low-quality or spurious drugs.
Procurement is always through a public tender that awards the contract to the lowest bidder—a practice that most doctors, drug makers and health-care experts blame for making the public health-care system vulnerable.
This “lowest cost” approach keeps away reputed manufacturers, who will not compromise with quality for fear of diluting the value of their brands, and lures the ones who participate to pull down costs even at the cost of losing quality, say critics of the system such as Harinder S. Sikka, a director with drug maker Nicholas Piramal India Ltd. Sikka is leading a litigation against the government on spurious drugs, as reported by Mint on 30 April in a page-one story on a thriving market for fake drugs in Delhi.
Most government agencies have a drug purchase committee, with consultants and specialists on it. This panel sifts through medicine lists prepared by in-house doctors and calculates the likely total demand for the coming year. A tender is floated thereafter, with technical requirements outlined, and bids invited. The lowest bidder walks away with the supply contract. “The government agencies have to buy in bulk and disburse it to as many people as may be in need of these medicines. Hence, the stress is on procuring cheaper drugs,” says Anil Bansal, former president of Delhi Medical Association, who is also a doctor with New Delhi Municipal Corporation (NDMC) that operates 13 dispensaries and two hospitals in the Capital.
Doctors get different results while using the same drug sourced from government outlets, and so are uncertain of the therapeutic efficacy. Dr A.K Bisoi, a cardiac surgeon at AIIMS, says that while carrying out valve-replacement surgeries, the same dosage of a blood-thinning drug such as Heparin shows a discernible difference in efficacy depending on whether it was bought from the market or from stores of the Central Government Health Service (CGHS). Variants of heparin drug are made and sold by roughly two dozen manufacturers including Ranbaxy Laboratories Ltd, Intas Pharmaceuticals, Lupin Ltd and Sanofi Aventis SA.
“It is the same for drugs that treat high blood pressure and seizures,” adds Bisoi. “Drug impurities also manifest themselves through allergies, flushes etc., and it is a serious clinical threat as one never knows the exact therapeutic extent to which a drug will work.” Bisoi says he doesn’t believe that drugs procured at government hospitals are randomly sampled or manufacturing facilities that supply these drugs checked periodically.
Officials in the ministry of health and family welfare, director general of health services and CGHS kept directing Mint’s queries from one office to another, or would not return calls for comment, or requests for interviews.
But one CGHS official admitted there wasn’t a practice of routinely picking up a few samples from each batch for quality test. At MCD, an official claimed random testing indeed took place and tests were done at labs such as Sriram Laboratory of Industrial Research in Delhi. Both officials requested anonymity. An executive at Sriram Laboratory confirmed that samples from the Delhi government came to them for quality testing and only “a small percentage” was found substandard.
Arti Mehra, the mayor of MCD, says checks are in place but not foolproof. MCD procures Rs22-Rs25 crore worth of drugs annually. “We (elected representatives) come and go but these people (mischief-makers) have a nexus and stay there. Even if we blacklist companies, they change names and come back in to the system,” she says.
Diabeto-cardiologist Dr Anil Gomber, who works in Max Hospital currently but was in a government hospital years ago, says some government rules such as buying in bulk without proper packaging and then distributing in smaller quantities to patients can be dangerous. “(Government hospital) systems are not transparent. Non-branded drugs are given out in open plastic bags which can cause maximum damage, as there is no stamp of the name or company and the quality is uncertain,” he said. “There are dangers of under-medication or over-medication that can cause complications. These (practices) should be simply be banned,” he added.
Government hospitals also don’t have a foolproof system in place to destroy expired drugs. An NDMC official, who too did not wish to be named, said doctors in the corporation’s dispensaries preferred to destroy or dump drugs that were not consumed as the process of returning drugs to the sourcing department was too bureaucratic. “While the upright doctors choose to destroy them, the crooked might resort to selling them too,” he added.
Vijay Karan, an ex-police officer who is now heading Indian Pharmaceutical Alliance’s cell against counterfeit drugs, feels that the public health system “is in the pits”. Karan was instrumental in bringing to light Unisule’s substandard drug supplies four years ago.
Yet another problem is the lack of coordination among government departments. For instance, there is little chance that a drug supplier contracted in a government tender and later blacklisted by the Drug Controller General of India will be barred from supplying to the government hospital or department. It is only when a whistleblower or a rival company flags it that it will get noticed by the sourcing department, but when often, like in Jharkhand, it is too late.