Plug loopholes in drug regulation

IN PERSPECTIVE

When 17 children between two months and six years of age suddenly fell ill and 11 of them died rather mysteriously within a span of 15 days in Ramnagar area of Jammu & Kashmir in January, it was initially attributed to food adulteration. Following a public outcry and detailed examination by medical experts, a PGIMER Chandigarh lab found prima facie the presence of diethylene glycol (DEG) in samples from a batch of Coldbest-PC Syrup manufactured by the Himachal Pradesh-based Digital Vision Pharma (DVP).

It is suspected that DEG could have triggered renal failures. The results of syrup samples being analysed at the government laboratory in Chandigarh can provide valuable inputs. If the medicine was indeed contaminated, a jail term of 10 years extendable to life imprisonment, along with a fine of Rs 10 lakh or three times the value of the drugs confiscated, can be slapped on the company.

Digital Vision Pharma’s licence has since been cancelled and production of the syrup discontinued. Efforts are underway to recall the particular lot of 5,500 syrup bottles which had been released into the market during September 2019 across Jammu, Haryana, Punjab, Tamil Nadu and the North-East.

The company is already in the dock, according to reports, for selling drugs ‘not of standard quality’ (NSQ) in Rajasthan, Maharashtra, Karnataka, Gujarat and Kerala. The Union government-sponsored National Drug Survey 2014-16, too, found that out of eight samples of its products, four were found to be sub-standard. Last year, the country’s apex regulatory authority, the Central Drugs Standard Control Organization, found that DVP’s Rabeprazole Sodium tablets (used for controlling acidity) and Glimeride (diabetic drug) were sub-standard.

The Ramnagar tragedy clearly shows that there were lapses in testing the syrup at the plant level before releasing them into the market. More importantly, why should it happen in the first place as the ISO 9001:2000 company is also said to possess a “good manufacturing practices” certificate. Had the regulatory authorities systematically and consistently drawn samples of drugs released into the market, the tainted September 2019 batch of the syrup would have possibly been unearthed much earlier, and lives could have been saved.

With a whopping 20,000-odd pharma units spread across the country that need to be monitored and their samples tested periodically, there is a need to thoroughly assess the existing procedures and plug the loopholes. Drugs must be analysed regularly and in a timely manner. When drug samples fail on quality, its production must be stopped immediately and stocks sold must be recalled from the market.

Even now, it is not late for the local regulator in Himachal Pradesh to carry out an in-depth quality audit of DVP as it can provide valuable insight into several unanswered questions. How did DEG, a known poison, get mixed with the pharmaceutical preparation that was solely meant for human consumption? At what point in the manufacturing process did the contamination occur? Was it deliberate or accidental? etc.

About 50 million patients avail of consultation or take treatment daily from about one million doctors in India. One cannot say what runs inside a doctor’s mind while he is prescribing a certain drug to the patient. But what’s known is that pharma companies adopt a variety of strategies, many of them prohibited by Medical Council of India guidelines and judicial pronouncements, to push their products through these doctors.

Indeed, pharma companies even claim and obtain tax exemptions for what are essentially “sales and promotion expenses.” On January 9, while hearing a tax appeal of the Income Tax Department against an order of the Income Tax Appellate Tribunal which ruled in favour of pharma major Fourrts India Labs Private Limited, the Madras High Court took suo motu cognisance of unethical practices in the medical industry.

The I-T department contested the tax exemption claimed by Fourrts to the tune of nearly Rs 5.46 crore which was incurred on licences and taxes and about Rs 43 lakh towards “sales and promotion expenses,” including payments made to doctors for promotion of its brands of medicines for the assessment year 2012-13. Observing that close to 9,000 companies had claimed income tax deductions for “sales promotion expenses” and “gifts”, the court has sought details of the number of pharmaceuticals existing in India since 2015 and particulars of the number of companies which have claimed tax deduction under promotional expenses since then.

With an overwhelming 70% of the medical expenses in India being met out of pocket by individual patients, there are many unanswered questions. Are drugs overpriced? How do many doctors get away with prescribing unnecessary drugs at the instance of pharma companies? etc.

It is mind boggling as to what goes on behind the murky smokescreen of the healthcare sector. There is indeed much to be done to clean the Augean stables: the task is Herculean as the rot runs deep.

All that patients believe is that their doctor would prescribe the best medicine and advise them of the most effective treatment for their medical problem.

(The writer is studying Forensic Science at Galgotias University, Greater Noida)