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Is it safe to have that capsule?

In April this year, the Chhattisgarh government received the report of an injection sample that had been sent to the Kolkata-based Central Drugs Laboratory for testing. It sent the department into a tizzy. The injection, lignocaine, a common local anaesthesia, had been used in the government-organised cataract camp in the Balod district in October 2011. Forty-four people had lost their eyesight after the surgery. “The sample of injection contained fibres and a few black particles,” read the Central Drugs Laboratory report, a copy of which is with Business Standard.

The laboratory stated that “the sample (lignocaine injection) referred to is not of standard quality as defined in [the] drugs act 1940”. Copies of the report were marked to the Drugs Controller General in New Delhi and Chhattisgarh’s Controller for Food and Drugs.

This should have been a wakeup call for the Chhattisgarh government. It wasn’t. Seven months after receiving this damning report, the state government again finds itself in a spot. Fourteen women lost their lives due to suspected contaminated drugs and botched-up surgeries conducted in three sterilisation camps in the Bilaspur district on November 8. The Ciprocin 500 tablets given to the women who underwent tubectomy are said to have been of substandard quality. Traces of zinc phosphide, a component of rat poison, were found in the premises of the drug’s manufacturing unit, Mahawar Pharma, which was operating out of a bungalow in Raipur. Within days of the incident, drugs at the unit, owned by Ramesh Mahawar, were set on fire. Mahawar, who has since been arrested along with his son, Sumit, hasn’t explained why. Before his arrest, Mahawar said that all the allegations levelled against him and his company were baseless. In a statement, he said that after a free and fair probe, he would be given a clean chit. The state government has, meanwhile, seized the entire stock and banned its use.

Mahawar Pharma is not the only little-known company manufacturing drugs in the country. While the National Pharmaceutical Pricing Authority lists about 10,000 pharmaceutical units in India, J S Shinde, president of the All-India Organisation of Chemists and Druggists, says about 20,000 units are in operation. Monitoring these many companies is a regulatory nightmare. “There are several smaller ones that manufacture and sell their drugs in localised areas. They tie up with retailers and doctors and offer high profit margins on their medicine,” says Shinde. Only about 300 companies, which are familiar names, account for 98 per cent of sales, adds D G Shah, secretary general of the Indian Pharmaceutical Alliance. “The smaller companies operate in states and districts and supply to the municipal corporations and local hospitals where political patronage matters a lot.”

In Chhattisgarh, for example, the government’s drug purchase policy is tilted heavily in favour of local manufacturers. Under the store purchase rules, the company manufacturing products within Chhattisgarh gets a price preference of 20 per cent. The ‘make-in-Chhattisgarh’ policy could have led to unqualified people entering the medicine manufacturing business, resulting in the circulation of substandard medicine in the market.

Unscientific inspection
Also questionable is the manner in which drug manufacturing units are inspected. Between 2011 and 2012, the Chhattisgarh drugs department had declared substandard 13 of the 17 samples it collected from Mahawar Pharma. Licences for another seven products were suspended for six to nine months. Despite this, the drugs department had issued ‘good manufacturing practices’ certificate to Mahawar Pharma for 2014. The drugs controller of Chhattisgarh is required to inspect manufacturing units once every three months. In Raipur, Deputy Drugs Controller Hemant Shrivastava was assigned the job. He has been suspended for the negligence.

“Inspection at both state and central level is poor and unscientifically done,” says Chandra M Gulhati, editor, Monthly Index of Medical Specialties, a watchdog for human trials of drugs and vaccines in India. Sample collection, too, should be scientific, he adds. “Inspectors should pick enzyme samples and drugs that are nearing expiry, basically those things that go bad very soon,” says Gulhati, adding that the Central Drugs Standard Control Organization’s contention that only about 6-8 per cent of drugs are of substandard quality is on the lower side.

In the US, there is a follow-up inspection after one inspector has surveyed the unit, says Shah. “The second inspector reports what the first inspector might have missed, and that is reflected in the record of the first inspector. We don’t have that system. The whole administration is lax.” Inspectors are bribed and licences earned, he adds. Besides, the inspection system in America is of preventive nature and is done not just with the purpose of nailing and nabbing manufacturers of substandard or spurious drugs, adds Gulhati. For the record, Indian pharmaceutical companies have been under fire from the US Food and Drug Administration for violation of good manufacturing practices.

“In theory, every drug manufacturing unit should have a full-fledged, well-equipped and adequately-staffed quality control laboratory. In practice, very few possess such mandatory facilities that cost quite a bit of money not only to install but [also] to run and maintain,” writes Gulhati in his magazine.

To put the blame entirely on manufacturers would, however, amount to looking at half the picture. Responsibility needs to be fixed on distributors and retailers as well because how the drug is transported and stored and refrigerated in chemist shops also affects its quality. “In Siliguri, for example, I came across 15 chemists who chose to keep chocolate instead of penicillin injections in the refrigerator because chocolate would melt,” says Gulhati. (Penicillin solutions have to be stored in a refrigerator at 2 degree Celsius to 8 degree Celsius). Many chemists, particularly in semi-urban areas, don’t have functioning refrigerators, he says. Some turn them off on holidays, and then there is the problem of load shedding, all of which adversely affects temperature-sensitive drugs.

Shinde of the All India Organisation of Chemists and Druggists, which represents about 750,000 chemists, both retailers and wholesalers across India, counters, “Both consumers and sellers are more cautious these days. They will not take such chances.” The greater challenge lies in monitoring manufacturers. There is nothing preventing small-time manufacturers from producing fake or spurious drugs named after bigger and credible brands, he says. “These manufacturers might fill a capsule with glycerine, glucose or even turmeric powder and package it so authentically that even a chemist or stockist would not be able to tell the difference,” he says. “The factory of this manufacturer might be in Delhi but there is no stopping him from selling his products anywhere else in the country. The drug controllers of those other states will not even bother to inspect this medicine,” Shinde adds. His advice to people is: “Buy medicine only from those chemists who know you. There is less chance of them deceiving you. Also, don’t fall for heavy discounts.” Shinde says his organisation advises retailers to buy drugs only from the authorised stockists of credible companies.

The tedious reward process
Five years ago, the Central Drugs Standard Control Organization had launched a ‘reward scheme for whistleblowers’ to check the menace of substandard and spurious drugs. The policy stipulates that the reward of a maximum of 20 per cent of the total cost of consignments seized or Rs 25 lakh (whichever is higher) would be paid to the informer. And if the informer is a government officer or an officer of the Central Drugs Standard Control Organization, the reward would not exceed Rs 5 lakh for one case and a maximum of Rs 30 lakh for the entire service. The reward would be given only when there would be confirmation of the seizure of spurious drugs, cosmetics and medical devices by the organisation’s designated officers. In the last five years, not one person has been awarded under this scheme.

One of the flaws in the scheme is said to be the long-drawn process. The rule says, “In order to ensure the continued cooperation of informants, 25 per cent of the amount is to be awarded at the time of filing of the case in court, another 25 per cent upon a favourable disposition of the case at the first trial level, and the remaining 50 per cent upon final disposition in favour of the government with no appeal pending.”

It’s a tedious process. “Besides, I wouldn’t like to be a whistleblower in our country. There’s no protection. Have you seen how many whistleblowers have been killed?” says Gulhati. As of now, a solution to the problem of substandard and spurious drugs appears far from sight.

Substandard versus spurious
A nationwide survey found that spurious drugs in India account for 0.046 per cent, while the extent of substandard medicines is around 6 per cent. There have been smaller inspections since (see table).

Though the terms are often confused, there is a distinction between substandard and spurious drugs. Spurious or fake are those that use someone else’s popular brand name to pass off their own drugs. “Or, say a drug claims to be a paracetamol but has no paracetamol in it, then it is a fake,” says Gulhati. Substandard drugs, meanwhile, are genuine medicines that do not meet the required quality specifications.

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