Indu Gilra, a retired teacher in her seventies living in Indirapuram, Ghaziabad in the national capital region (NCR), would often pop a tablet of Combiflam at the slightest hint of body ache. Since it’s an over-the-counter medicine, she could purchase it anywhere and it had always worked. One day, however, the pain refused to subside hours after taking the pill. Worried, she doubled her dose and yet the pain wouldn’t budge.

“I kept wondering if I had contracted some serious disease,” she says. She also wondered if there was something wrong with the medicine – she had bought it from a chemist’s shop which had opened recently in her middle-class neighbourhood. Maybe she should change the shop and not the medicine, she thought. Indu’s pain was gone after buying a strip of the same medicine from another pharmacist.
“I could make out that I had been popping spurious drugs all these days, but what could I do?”

Upset at being cheated she now decided to spread the word about her experience and at least expose the pharmacist before others. Her friend and neighbour Jaya Bhat, 74, was suffering from hypothyroidism – a condition in which a small gland located deep inside the neck region becomes sluggish and does not produce enough thyroxin hormone that plays a key role in working of the human body. For years, Jaya had been popping a 50 mg pill of Thyroxin in the morning to allow her body to make up for the missing hormone. However, of late, she had been feeling very uncomfortable, suffering palpitation, feeling extreme cold even in the peak of Delhi summer and her body bloating.

Interview | Drug regulatory structure is not sound: Whistleblower, Dinesh Thakur

Fearing that her thyroid condition might have worsened, she got her blood tested. The doctor saw the report of the clinical test and told her that the gland had become even more sluggish and now she needed to double the dose to compensate for ever lower levels of thyroxin.
One day when the neighbours met during a routine walk they exchanged notes on health. Indu let out her rant against the new chemist. “I was lucky to have met Indu that day,” recalls Jaya, a homemaker, who too realised why she was continuing to suffer even after doubling her dose of medicine. She too changed her druggist and heaved a sigh of relief.

She has since returned to the 50-mg pill regime. “Only last week I got my blood tested for thyroxin and the result was normal,” she says.
The two women not only wasted money and suffered pain and anxiety but also consumed chemicals which could have major side effects on their health. Unfortunately, Indu and Jaya live in a region – NCR Delhi – which sees a '300 crore substandard drugs trade each year. According to the industry body Associated Chambers of Commerce of India (ASSOCHAM), a third of the drugs sold in this region comprising the capital and the four townships around it – Noida, Ghaziabad, Faridabad and Gurgaon, with a total population of 4.6 crore – are substandard. The report is based on a survey it carried out in 2006-07.

A substandard market

In Indirapuram, Dr Yatendera Kumar Bansal, a popular general physician whose clinic in Gyan Khand is flocked by all – from residents of the high-end apartments to the construction workers living in shanties outside – has to deal with the issue of quality of drugs each day. During his 25-year career, he says, his biggest worry has been how to save patients from substandard drugs.

“As there is good supply of spurious medicines in the market I prefer to prescribe medicines of big companies and brands,” he says.
For the pharmacist, selling sub-standard medicines – called ‘Not of Standard Quality [NSQ] drugs’ in official parlance – is good business since it would fetch him 25 percent profit as compared to 5-10 percent on the genuine ones. Dr Bansal says, “There is no surveillance; there is no drug regulatory regime in place. Today as a doctor, I feel that even trusting big brands is a risk.”

The doctor says unscrupulous pharmacists pass off substandard medicines to unsuspecting patients as cheaper versions of the one prescribed by doctor. “At places, drug sellers turn into ‘doctors’ prescribing people common drugs which are fake or substandard. Poor people think they have saved on the consultation fees of a doctor and expensive medicines but they are in no position to realise that these chemicals are making their bodies drug-resistant.”

Drug inspectors, Dr Bansal says, are hardly seen around. At times, they do come to pick samples – which they are supposed to do secretly – and many of them are easily bribed by pharmacists. 

Over the years, Dr Bansal has been seeing a growing number of patients with drug-resistant tuberculosis. “It is the direct result of people being fed substandard drugs. This will soon turn into an epidemic but unfortunately we have no way to control it.”

His observations are backed by the ASSOCHAM report, titled ‘Fake and Counterfeit Drugs in India – Booming Biz’. It says that in India, fake drugs constitute '27,823 crore ($4.25 billion) of the total '92,743-1,12,616 crore ($14-17 billion) of the domestic pharmaceutical market. The report has warned that the size of the substandard drug market would cross '66,245 crore ($10 billion) by 2017.

Regulation regime

At the heart of the problem is an outdated and confused drug controlling regime in India that is governed by a pre-independence law – the Drug and Cosmetics Act, 1940. Under it, there are 36 different regulators for drugs – one in each of the states and union territories and the central body. The law enjoins the state regulatory bodies to issue licences for the manufacture and sale of drugs and also check these for quality while it leaves the centre with the job of controlling import and exports, introduction of new drugs in the country and the overall supervision. The fund-starved states have invested neither in good laboratories nor in hiring experts to keep tabs on drug makers. On the other hand, the role of the Drugs Controller General of India – which has been renamed as the Central Drugs Standard Control Organization (CDSCO) to create an impression that it is the apex drug authority – remains limited to issuing licences for imports and issuing permission for the entry of new drugs into market.

Enter the whistleblower

Dinesh Thakur, who after blowing the whistle off the Indian pharma major Ranbaxy’s supply of substandard drugs in the US in 2013, has launched a campaign for safer drugs for Indians. As part of it, he did a reality check on efficacy of the drug regulatory regime in India and came across shocking results (see interview with Dinesh Thakur).

He discovered that barring Kerala and Tamil Nadu, no state government had made allocations for the food and drug inspectors to buy medicines from market for random checks. In a response to his RTI query, Thakur got a district-wise breakup of expenses made on the purchase of samples by inspectors from the market in Kerala and Tamil Nadu, while other states were either mum or admitted that they had no specific budget for this basic exercise.

He discovered that drug inspectors had mostly picked samples of low-priced and commonly used drugs like antacids, steroids, anti-inflammatory medicines, cough syrups and painkillers but not the exorbitantly priced cancer drugs.

His research also revealed that it was business as usual for the pharmacists and drug-makers even after they were caught making substandard stuff for human consumption. In one case, an inspector had picked samples of Tinidazole, an anti-parasitic drug, from the drug store of the state entity Andhra Pradesh Medical Services and Infrastructure Development Corporation (APMSIDC) at Vizianagaram in January 2010. A Hyderabad-based laboratory took full 19 months to establish that this particular drug was of poor quality. Thereafter, the inspector tracked the source of the sample to a Madhya Pradesh-based factory. It took him 30 months to complete the investigation and present the case in a court of law. In the meanwhile, 10,000 tablets of this particular batch of drug had already been sold off and consumed by hundreds of unsuspecting patients.

On tracing the fate of other investigations into cases of substandard drug, Thakur found that drug inspectors across India lacked technical and legal expertise to investigate and frame watertight legal cases against the defaulters. “They are making cases only to show that cases are being prepared and instituted in court and finally tell the people that courts have discharged or acquitted the accused persons and thus save their skin,” he wrote in his blog. This entry came after the supreme court in March dismissed his PIL seeking its intervention to improve the standards of regulation of the Indian pharmaceutical industry.

After analysing drug inspectors’ methods of booking the accused, Thakur felt that the government was simply wasting money on food and drug departments and it should take a serious view of revamping them with strict accountability fixed for each official.

A more worrying fact is that many of the identified substandard drug samples come from government hospitals, alluding to a nexus between babus and fake drug-makers.

According to a Comptroller and Auditor General (CAG) report of 2008-09, at the armed forces medical stores (AFMS), a centralised procurement agency for military forces, the rate of rejection for locally procured medicine had increased from 15 percent to 31 percent from 2006-07 to 2010-11 as more and more samples failed quality tests.

No wonder, a senior naval officer, whose wife was being treated for cancer in Delhi’s prestigious Army Research and Referral Hospital, made it a point to never take free medicines from the hospital and instead purchase these from reliable medical stores outside the AIIMS at high prices. “I trust the doctors but not the medicines they feed the patients,” says the officer who didn’t want to be named.

Gujarat is the only state which had set up an authority, Gujarat Central Medical Stores Corporation Limited (GMSCL), for procurement and distribution of safe drugs across the state. Set up in 1978, the corporation was entrusted with procurement, storage, distribution of drugs, surgical goods and other equipment for the state institutions. The corporation is supposed to check each batch of the drug before supplying it to the institutions to ensure no substandard drugs reach the patients. But a CAG report for 2014-15 submitted on March 31 this year, has found huge discrepancies in the functioning of GMSCL leading to a continued supply of substandard drugs to the government healthcare facilities. It has found that since laboratories take long to analyse samples, the GMSCL was dispatching medicines even before these were cleared for quality.

The CAG found that 55 percent, or more than half, of the stocks of drugs which were found ‘NSQ’, that is, substandard, had already been distributed to patients before the laboratory certification had come. The GMSCL has since promised to make amends though it has not given any roadmap to the CAG.

Courts too, it seems, tend to take a lenient view of the crime of making substandard drugs, as was found by Thakur’s team in reply to their 100 RTI queries sent to different central and state government agencies.

The team studied six judgments of a Bengaluru-based special court for economic offences. In all these cases, the court had waived off the minimum sentence of one year imprisonment and a fine of '20,000 under the Drug and Cosmetics Act. Those held guilty of poisoning human bodies through badly made medicines were exempted from punishment on flimsy grounds like “he has a family to look after” and “his mother was suffering from serious health issues”.

“The court justified the lenient punishment with the reasoning that the charge against the accused was one of selling drugs which are not of standard quality, as opposed to the more serious offence of selling counterfeit medicine,” Thakur, who divides his time between Gurgaon and the US and carries on his campaign for safe drugs for Indians, wrote in his blog.

Courts and many others feel that substandard drugs may not be as harmful as outright counterfeit drugs and hence show leniency to culprits. However, doctors feel that substandard drugs can often cause as much harm to the body as the counterfeit or fake drug.
Doctors say a substandard anti-biotic would not only be ineffective in controlling a disease, but its use will also make pathogens (germs) resistant to the drug, leading to multi-drug-resistant TB, which is becoming dangerously common in India now.

A study by Johnson and Holt published in the British Journal of Clinical Pharmacology notes, “Although falsified drugs [spurious drugs] have perhaps received most of the attention with respect causing unnecessary deaths, substandard manufacture also leads to morbidity and mortality. The inadvertent use of suboptimal dose of drugs is likely to be one of the key factors contributing to antimicrobial resistance and thereby leading to the wider spread of disease.”

Reform blueprint

Dr Raghunath Anant Mashelkar, an eminent scientist who had a long and distinguished career as the director general of the Council of Scientific and Industrial Research (CSIR) – “the world’s largest chain of laboratories”, had laid out a blueprint for a robust drug regulatory regime in India. The committee headed by him in its exhaustive report in 2003 had recommended setting up a centralised regulatory authority – a National Drug Authority on the lines of the US Food and Drug Authority (USFDA). This would do away with the multiple regulators, which today often work in isolation or, worse, at cross-purposes. The committee had also proposed death penalty for those playing with people’s health by making substandard drugs (see box for the highlights of the report).

While the industry welcomed Mashelkar’s recommendations, it created a storm in political circles with states accusing him of seeking to curtail their powers. 

The Mashelkar report has been gathering dust although the government had twice tried to introduce a law based on his recommendations. In 2007, the proposed bill was withdrawn after members objected to withdrawing the states’ power to issue licences for manufacture of medicines, while the one introduced in 2013 has been entrusted to the standing committee for further deliberations.

In the meanwhile, doctors seem to be making the most of the free-for-all drug regime. Dr Bansal once came across a cancer patient who was being given a drug without prescription at as prestigious an institution as AIIMS. “I was shocked. He was put on a human trial of a drug made by a US company without his knowledge. I realised how foreign companies were misusing India’s lax regulatory system in connivance with some greedy and unscrupulous doctors,” he says.

aasha@governancenow.com

(The story appears in the May 1-15, 2016 issue)