MUMBAI: The deaths of 69 children in the West African country of Gambia due to contaminated cough syrups have rekindled memories of the city’s own deadliest encounter with adulterated glycerol. In January 1986, 14 patients between the ages of 10 to 76 suffered kidney failure and died at the state-run JJ Hospital due to the consumption of glycerine laced with a cheap industry-grade adulterant.
Thirty-six years later, several reforms suggested in the wake of the incident remain on paper. Worse, there are still no adequate checks and balances to prevent toxins from finding their way into life-saving medicines yet again.
The JJ deaths had led to an outcry, forcing the government to form an independent commission led by Bombay HC judge Justice Bhaktavar Lentin. The report submitted in November 1987 exposed the ‘apathetic’ administrators of JJ Hospital, the ‘corrupt’ officials from Food and Drug Administration (FDA) as well as state health department, whose collective failure to ensure drug safety and recall led to the deaths. He also made a slew of recommendations, both for JJ and FDA.
The report recommended two deans for an institution of JJ ‘s size – one for medical affairs and another for administration. While the associate dean post was created, it has been vacant for six years. As for FDA, Justice Lentin called for sweeping reforms starting with having an ‘assertive commissioner of proven administrative ability’ to stringent implementation of the Drugs and Cosmetics Act.
A cursory glance by TOI into FDA operations didn’t instill much confidence. The FDA, responsible for over Rs 15,000-crore pharma industry, runs with a staff deficiency of 54%. Against the state’s requirement of 800 drug inspectors, there are only 200 sanctioned posts; of which 83 (41%) are filled. Out of 67 assistant commissioners, 43 po-sts are occupied. In the case of joint commissioners (drugs), seven of the eight sanctioned posts are vacant. “Goa, with a 15 lakh population, has 10 drug inspectors, while Maharashtra has 83 for 12 crore people,” said an official.
Why are these vacancies worrisome?
Maharashtra has 90,000 retailers, 28,000 wholesalers, 1,000 allopathic drug manufacturers, 450 ayurveda drug manufacturers and an equal number of firms making cosmetic products, in addition to 360 blood banks, but the workforce shortage renders supervision non-existent or perfunctory, an official said. The crisis extends to its labs too, impacting post-market surveillance and drug recall. The three labs in Mumbai, Aurangabad and Nagpur collectively test 5,000-odd drug samples. Reports take two to three months, and here lies a critical problem in recalling or acting against ‘not-of-standard-quality’ (NSQ) drugs, said an officer. The shelf-life of a fast-selling drug is between 30 and 55 days. “By the time the samples are collected and the NSQ report comes, the batch is over,” the officer said, adding that only 35 of 89 sanctioned chemists’ posts are filled.
But former FDA chief Mahesh Zagade believes that the department’s failure to ensure drug quality is not about manpower, but the willpower to act against erring companies. “The corruption is so rampant that having more vacant positions works to their advantage. There is a hafta culture across India. More the number of vacancies, the more the area officers get to command,” said Zagade, who added that the repeat of glycerine-adulteration incidents shows that companies are getting away without mandatory testing of raw materials or finished products. “The system wakes up only when there are deaths. What about those living with the side effects of adulterated medicines?”
JJ authorities told TOI that if there is another drug reaction incident, they would have to make calls and alert departments since government hospitals work without the Hospital Management Information System.