Made in India
Pushing public health to life-threatening dangers, substandard drugs are flooding the Indian market
Akash Bisht Delhi
Rajinder Man, An Inspector-General with Border Security Force, was fighting a fatal battle against bone cancer. The doctors prescribed an imported drug to help cure the disease. Mani bought four doses of injections from a Delhi-based pharmacy and soon discovered that the medicine provided him no relief. He approached the doctor and all hell broke loose when he was informed that the injections he had bought were spurious. Mani was then asked to buy the drug from its sole legal distributor in India. But, by then, the damage had already been done. Mani had to go for a hip replacement surgery.
However, after the surgery, Mani approached the consumer court in Delhi. The court ordered the pharmaceutical distributor to cough up Rs 10.5 lakh as damages for aggravating his condition. Mani had a lucky escape, but many others who are unknowingly consuming spurious or substandard medicines in India are dying a slow death. Experts believe that the hullabaloo surrounding the large circulation of fake drugs penetrating Indian markets is exaggerated and basically substandard drugs should be the cause of grave concern.
Dr CM Gulati, editor, Monthly Index of Medical Specialities, refutes the claim that largescale spurious drugs are penetrating the market. He believes that claims of massive spurious drugs penetration is multinational propaganda, while manufacturing fake drugs is an idiotic proposition. "The high-end technology used for packaging medicines is very expensive and it would not yield any profits. If the manufacturer is not making any profit, why would he consider it? Additionally, there is always the fear of being caught," says Gulati.
Ravi Kant, Assistant Drug Controller, Drugs Control Department, Delhi, corroborates Gulati's views and calls packaging a costly proposition. Experts believe that the limited mandate to control the menace either at the policy or enforcement level is a cause of worry not only for consumers but also for genuine producers and enforcement agencies.
Upholding the fact, the data from drug testing laboratories across the country too gives a dismal picture of the quality of medicines being marketed in India. From 2004 to 2009, more than 2,07,142 samples were randomly picked by state-level drug inspectors and it was found that more than 7 per cent were of substandard quality. "This is what the focus of the authorities and media should be rather than unnecessarily claiming that a high percentage of spurious drugs are circulating in the market," says Dr Gulati.
CBI sources confirmed to Hardnews that many factories that produce legitimate medicines during the day resort to substandard ones during the night.
A recent report, A Safe Medicines Chest for the World, brought out by the International Policy Network, exposed that a dangerously high 12 per cent of drugs supplied by Delhi pharmacies were substandard, while it was 5 per cent in Chennai. The report read: "While the majority of drugs were of high quality, it's worrying that 80 per cent of the sampled Delhi pharmacies were providing substandard products. In Chennai, the situation was much better, but there remained a 38 per cent chance that the pharmacist (in Chennai) would be doling out substandard medicines."
The report mentioned that 50 per cent of pharmacists interviewed in Delhi and Chennai revealed that the most popular way of counterfeiting was by repackaging expired drugs. "In Delhi, 7 per cent of samples from intermediary wholesalers were substandard and 80 per cent of the pharmacies sampled were providing at least some substandard products, twice as high as Chennai."
Recently, Central Bureau of Investigation (CBI) conducted a countrywide drive to check adulteration of drugs, substandard drugs and other offences under the Drugs and Cosmetics Act, 1940. CBI registered six cases in Delhi, Nagpur and Chennai. The surprise checks were conducted to check the supply/manufacturing of spurious drugs, sale of expired medicines, supply of substandard drugs through Central Government Health Scheme (CGHS)/railways hospitals/other government channels and manufacturing of medicines without licence et al.
"During surprise checks, it was found that the substandard medicines and expired medicines are being supplied to CGHS dispensaries and government hospitals. It was also found at many places that spurious medicines, particularly ayurvedic medicines, are being manufactured without licence from the competent authority," says Rajiv Singh, DIG, CBI. Singh adds that these drugs are entering Delhi through neighbouring states that host dava mandis that specialise in spurious and counterfeit medicines.
Gulati believes that counterfeiting a brand name does yield high profitability and makes sense for these manufacturers. "But that is not my concern because most of these medicines have active ingredients and these do not put public heath at risk. If brands are so concerned, why don't they cut their profits and sell their products at a lesser cost," he says. This, he believes, would destroy the counterfeit market.
An official at Ministry of Family Health and Family Welfare confirms Gulati's views. He informs that the production cost of most of the brand name medicines being counterfeited are close to Rs 2-3 while they are sold at Rs 10-15. "These huge profit margins lure some to counterfeit the product. These counterfeits have similar composition and do not compromise on public health, but the problem arises when life-saving drugs are counterfeited," he says.
Argues Harinder Sikka, Director, Corporate Affairs, Piramal Healthcare: "A patient is entitled to safety from these fake medicine mafias. Unlike candies, these are life-saving drugs and can cause harm. These drugs should be put in the fake category because that is what they are." He stressed that profit margins are huge, luring manufacturers to make fake medicines. "If I am selling 80 per cent talcum powder instead of Psyprofloxis that costs Rs 3,000 per strip, then I am making huge profits. We make drugs with USFDA approval while these manufacturers need no such approval and are making medicines in dhaba- like environment. So aren't we putting patients' life at risk even if they have active ingredients?" he asks.
Sikka explains that drug manufacturers in India have Schedule M certification - good manufacturing practices and requirements for premises, plant and equipment for pharmaceutical products. "How many companies are complying with it? More than 50 per cent companies would fail Schedule M compliance and hence the drugs they are producing are way below the approved quality standards."
According to experts, at the core lies the issue of poor quality control monitoring by manufacturers and regulators. Theoretically, every manufacturer should have a well-equipped and adequately staffed quality control laboratory. Most manufacturers prefer not to invest owing to huge operational and maintenance costs. As per the Drugs and Cosmetics Act, once in a year, drug inspectors are mandated to review 10,563 manufacturing units for quality assurances.
The callous attitude of drug inspectors and manufacturers is acting as an impediment in the manufacture of quality drugs. USFDA banned entry of 31 products of Ranbaxy, one of the top drug manufacturers, after it found fault with its Paonta Sahib manufacturing unit. Ironically, the local drug inspectors had cleared it with flying colours.
Gulati points out that bad transportation and storage of medicines play havoc with their quality, and turn them into substandard ones by the time they reach consumers. "I have seen chemists keep insulin and other temperature sensitive medicines outside the refrigerator while chocolate bars are stuffed inside. Some turn off the refrigerator during weekly offs. Long power cuts in rural and semi-urban India are a norm. Temperature sensitive medicines are bound to degenerate in such an environment," Gulati says. In the present framework, manufacturers are hauled up for substandard medicines while the onus should also lie on the distributor and retailer. Gulati believes that the law needs a revisit.
In reply to the allegations, Kant says that chemists usually don't stock large quantities of temperature sensitive medicines. The problem of spurious drugs is not of such magnitude as reported in the media. Most counterfeits and spurious medicines come from neighbouring states, especially UP. "Delhi is a city of educated people who are aware of expiry dates, counterfeits et al. Delhi is more of a transit point from where drugs get supplied to other parts of the country," says Kant.
The shortage of staff with state and central drug controlling authorities hampers quality control and the monitoring process. "To adhere to Schedule M compliance, each factory must be reviewed by drug inspectors once in a year. There are only 210 drug inspectors to check nearly 10,500 units. It takes two weeks for two inspectors to review one unit. Thus, reviewing all of them is out of question," argues Gulati.
A drug inspector working with Delhi's Drugs Control Department agreed. He revealed that out of the total 51 posts for drug inspectors in Delhi, 23 are vacant; instead of 10 assistant drug controllers, there are only five. Even the laboratories employ staff on contract basis. "This forces us to do work that we aren't suppose to do. I have to look after the website while other inspectors are compelled to do some other work. This hampers the monitoring process and sampling can't be done as testing facilities are not up to the mark," he says.
The primary reason for failure, Sikka believes, is that the Central Drug Authority has no say in the working of the State Drug Authority. For every 500 chemists, there is only one regulator; only seven out of the total of 27 drug testing laboratories are functional.
Drugs made in India are sold all across the globe. Substandard drugs pose a grave threat to patients across continents and bring a bad name to India's reputation as a pharmaceutical giant. The International Policy Network report mentions, "In 2008, about half of all medical products detained at European Union borders came from India - most of them seized for imitating trademarks, meaning they were fakes... A similar team found that 35 per cent of the 195 anti-malarial drugs sold in shops and pharmacies in six major African cities failed basic quality tests: a third of the samples, purportedly of Indian origin, were found to be substandard. Although counterfeiters can lie about 'Made in India' just like any other aspect of packaging..."
Owing to huge substandard consignments, Nigeria banned imports from certain Indian pharmaceutical firms. In November 2009, Sri Lanka banned imports from four Indian manufacturers. Even Kenji Toda, chairman of the Japan Pharmaceutical Manufacturers Association, mentioned that bad reputation of Indian companies is a barrier to their growth in Japan.
Even the Mashlekar report in 2003 pointed to these gaps. Large number of prosecution cases pertaining to spurious drugs remain unresolved for years. "There is no greater deterrent than 'severe', 'sure' and 'swift' punishment. This problem needs to be solved squarely by making a separate provision for speedy trials of such offences," the report read.
Owing to a weak legal system, most perpetrators walk scot free and it's business as usual. "The laws of our country are such that 99 per cent of criminals are freed even after being brought into the judicial set-up. There are several loopholes within the law and criminals are well versed in exploiting these lacunae in the system. Until and unless laws pertaining to manufacturing of substandard drugs/counterfeit/fake drugs are made more stringent, it is impossible to control the menace," says a source in CBI.
Meanwhile, the Central Drugs Standard Control Organisation (CDSCO) recently revealed that only 0.3 per cent drugs in India are spurious and about 5 per cent counterfeit. However, the International Policy Network reports that the neighbouring states with porous borders have a higher percentage of spurious drugs as compared to Delhi. the report read: "Headlines that misleadingly dismiss the problem risk encouraging people to buy drugs from sources which supply substandard and counterfeit medicines - hence fuelling such trade."
In another move to reach to the common man, the department of pharmaceuticals in August 2008 started an ambitious Jan Aushadhi programme that intended to provide generic drugs at affordable prices to millions of poor patients. The intent was to sell drugs with their chemical names so that the prices remain far cheaper than the branded ones. However, the scheme didn't take off as expected and suffered major hurdles due to lack of support from bureaucrats and state governments, and hostility from multinationals and big drug companies that wanted to retain the biggest chunk of the Rs 50,000 crore industry. The programme intended to have 250 dedicated stores that would distribute these medicines, but the current figure is far from the mentioned target.
"In the last 60 years, government's expenditure on healthcare has been minimalist. The government doesn't have the will power or time for an issue that concerns the well-being of its citizens," says Sikka. "Substandard drugs cause equal harm to people as spurious drugs. Manufacturers who do this should be severely punished if the people of this country are to be assured a healthier and safer future," concludes Gulati.