Any post-surgical death has to be viewed with extreme seriousness. Fifteen deaths immediately after a minor procedure, as in the case of the Bilaspur sterilization camp, are deplorable. Our hearts must go out to all those families struck by this tragedy. We are heartened to note that “A single-member probe commission has been constituted and Retired District and Session Judge Anita Jha has been entrusted with the responsibility of investigation and to submit its report to State Government within three months. The Commission will investigate the case on following points of public importance: – 1) Was standard protocol followed in these camps? 2) What circumstances led to this incident? 3) Were the medicines used in these camps were of standard quality. 4) Who are the ones accountable for this incident? 5) What measures can be taken to avoid recurrence of such incidences? 6) Suggestions regarding Gender Equality in Family Welfare Programmes of the State. 7) This Commission for special probe of public importance is appointed by exercising its powers conferred under Section-3 of Judicial Commission Act (60 of 1952)”.
Let us hope that the findings of this Commission and its recommendations are acted upon and not consigned to the dust bin of history as with so many Commissions before this; but is worth examining the incident in the light of the parameters mentioned above.
The issue of protocol has been settled by “Guidelines for Standards for Female and Male Sterilization Services” published by the “Research Studies & Standards Division” of the Govt. of India, MoHFW in 2006. This was a result of Supreme Court intervention in Ramakant Rai vs. GOI, 2005 and reinforced in Devika Biswas vs. GOI, 2012. However, were these guidelines followed? As per the guidelines, a maximum of 30 operations are permitted if two separate laparoscopes are used. One individual doctor may not conduct more than 10 sterilizations per day. One therefore wonders how 83 surgeries were performed with a single instrument, in a single day over five hours. This works out to less than four minutes per patient. Any surgeon will agree that merely transferring a patient on and off the operating table will take at least 15 minutes with super-efficient staff. Chemical sterilization of the equipment (with cidex) should take at least 20 minutes as per standard guidelines. Autoclaving (using steam) takes a little longer. 83 cases are possible only if, as reportedly stated by the surgeon, the equipment was wiped with spirit after each procedure, and the scalpel reused. In these days and age this is reprehensible and must be condemned. The excuse of pressures to meet targets makes it even more disgusting.
Some of the women belonged to the Baiga tribe which is an endangered and protected tribe in whom the government has specifically banned any sterilization procedures. Thumb prints of dead women were taken on consent forms, who in life were able to sign their own names. The procedures were carried out in an abandoned charitable hospital which had been non-functional for more than a year. According to police reports, there were cobwebs hanging from the walls, cracked floors and rusted furniture lying around, and the patients were operated lying on the floor.
Interestingly, male sterilization accounts for less than 2% of the total procedures under this programme, in spite of the fact that it is safer, quicker, cheaper and requires less infrastructure than female sterilization. The family planning authorities have never gone down this road due to the obvious convenience of gender bias.
Death in the immediate post-operative period can only be due to a surgical accident (a vital structure or blood vessel being damaged) severe infection or drug induced. Initial reports indicate that there was no evidence of damage to vital organs or infection. It has now emerged that there was multi-organ failure due to Zinc Phosphide, a chemical used in rat poison, found as a contaminant in the antibiotic (Ciprofloxacin) used. This is criminal. The drugs were supplied by a firm (Mahawar Pharma Private Limited) which had been blacklisted for two years for similar offenses. The firm has since been raided and sealed.
The problem of spurious drugs is not new. It has been highlighted by a BBC sting operation more than a year ago. The definition of “adulterated” drugs in the Drugs and Cosmetics Act was amended in 2008.The penalty was also increased so that in the event of adulteration causing grievous hurt, the punishment is now 7 years to life imprisonment, with provisions for compensation to the victim. At one point even the death penalty was suggested for anyone causing death by adulterating drugs. As a principle, I am not a proponent of the death penalty; but I am a strong advocate of life imprisonment, for the life of the perpetrator, without any chance of parole and tagged with intensive community service.
“Partnership for Safe Medicines” has produced alarming statistics. 25% of medicines in developing countries are counterfeit. 60% have no active ingredients; 17% have inaccurate doses of correct ingredients; and 16% have incorrect ingredients. Our Union Health Ministry concedes 5% of drugs in India, worth about Rs.5000 crores are substandard. The BBC sting documentary revealed that there is a thriving counterfeit industry in India where orders are priced according to percentage adulteration. When the interviewer asked how much a consignment of spurious antibiotics would cost, the answer was “it depends on the percentage of the active ingredient”. The higher the percentage of the active ingredient, (which could be 50%, 25% or whatever you wish) the higher the cost. And the rest? Chalk, sugar or whatever. This on its own should have provoked suo-moto action by the authorities.
Adverse incidents due to fake medication jumped 11 times in 8 years with the Asian subcontinent accounting for the vast majority of cases. The more important question; has any action been taken, and how many instances are there of prosecutions resulting in convictions and penalties? The Mashelkar Committee’s report and recommendations, as indeed many before that, have largely been ignored. The procedure for drug testing remains outdated, slow, expensive, and grossly inadequate. “Out of the information received from 31 States/UTs, only 17 drug-testing laboratories were found to be functioning. Of these, only 7 were reasonably equipped and staffed. Some did not even have the bare minimum equipment” – Mashelkar Report. Other factors are shortage of drug inspectors, unduly prolonged judicial process, weak penal action, and undervaluation of human life.
It appears that there has been a colossal failure of administration as a result of which the patients were given spurious and contaminated antibiotics. This was the immediate cause of death. There has also been gross transgression of standard guidelines and surgical protocols by the surgeon; though this was not the immediate cause of death. Responsibility must be assigned and heads must roll if confidence is to be restored in Indian healthcare so that it achieves its true potential. Otherwise this nation will remain mired in total insensitivity to our less well-off countrymen.
(Dr Gladstone D’Costa is the Chairman,
Accreditation Committee and member, Executive Committee, Goa Medical Council. )
