Failure of drug regulator to ensure quality medicines!

By M.Y.Siddiqui

Recent deaths in Gambia, Uzbekistan and the USA, caused by toxic and contaminated medicines manufactured in and exported by India, has put a question mark on the oversight, efficacy and quality control mechanism of the drugs regulator, the Central Drugs Standard Control 0rganisation (CDSCO). Be it the quality control of both branded and generic medicines, their pricing, rampant manufacturing and marketing of spurious drugs across the country, collusion of National Medical Commission (NMC) and CDSCO, thriving of drug mafia impacting diagnostics, prescriptive medicines, commercialization of healthcare system as a whole are symptomatic of the malaise of all round failure of both the regulators, resulting in fleecing of the people. Medical doctors in private corporate hospitals working on periodic target basis for both diagnostic and prescriptive medicines, in case of failing to meet the target, are fired instantly, is yet another scam indicating crass commercialization and high costs of healthcare, happening with the connivance of the regulators. 

Other glaring scams are presentation of precious gifts to doctors, to those responsible for bulk procurement of drugs for their hospitals, funding of their foreign pleasure tours, even financing education of their wards abroad, all through benami transactions subsumed in broad marketing promotions expenditure in their annual balance sheets. Some other important ongoing scam is collusion between drug mafia, pharmaceutical industry and marketers of expired branded drugs with their date of manufacture, MRP, date of expiry erased ingeniously, new dates and other patent identity embossed on the expired drugs in bulk making such drugs fresh and marketed by online dealers at a hefty discounts, thus playing with the lives of people. Lack of accountability of the regulators is pervasive and in violation of all democratic norms and accountability of the government to the people. 

There is big money in the medical world and the entire healthcare system is riddled with massive corruption wherein drug mafia, medical education mafia and physicians (multi-discipline medical doctors) in government and private hospitals play major role in cahoots of both the regulators in total collusion with all stakeholders resulting in all round exploitations of the people. Only now the government has woken up to revamp regulators after India’s image as ‘pharmacy of the world’ has been tarnished. Earlier, M/s Ranbaxy, initially and for quite some time known as India’s largest drug producer with hyped high standards of quality, when investigated by the US regulators and others, fell from grace and ultimately was liquidated from the pharmaceutical world. It now stands dismantled with no trace of it with persons at the helm in that defunct enterprise  facing prosecution with some in jails.

Now that the union government has woken up to the menace of poor quality of medicines, unchecked mushrooming of spurious drugs and collusion among all stakeholders, responsible for quality control of drugs, its proper marketing, distribution with a contingency plan to do away with shortages of life saving essential drugs in emergent situations, lack of effective oversight mechanism, it is learnt from the union ministry of health and family welfare that a robust plan is underway to make drug regulators more efficient with credible oversight mechanism to revamp the drug regulators. 

For this to happen, CDSCO is being centralized for a better monitoring. However, the challenges of a new look oversight mechanism are very formidable when seen in the context of the current landscape of drug regulators. CDSCO, the central regulator with its zonal, sub-zonal offices and labs across the country, is responsible for approving new drugs, devices, clinical trials and laying down standards for drugs. Besides, each state and union territory has its own regulator as well, which is part of food and drug administration in the state. The state regulators look after licensing, auditing manufacturing facilities. There are 38 regulators in states and union territories. Problem arises with lack of integrated well-coordinated approach, in the process loosing control over quality. Simultaneously, officials together with inspecting personnel are most corrupt and they connive with the manufacturers, resulting in poor quality of medicines.

Union government foresees that a revamped centralized drug controller will result in improved standards of drugs that could be in keeping with the best of standards and quality of drugs as in the USA and Europe. But the US and Europe and most other countries deploy vast resources to make pharms maintain their own standards; whereas poorer countries rely on a list of manufacturers and inputs of the UN World Health Organisation (WHO). It is in this context that the Centre is working out common standards for drug regulators with a central database and removal of problems by a string of deaths to regulate production of better quality drugs on par with the best in the developed world of America and Europe, their marketing, reasonable pricing etc. According to an expert of the Institute of Cost Accountants of India, cost of a branded quality medicine is Rs. 6 for medicines costing Rs. 100 at the current costs of living making pharms businesses most profitable and for that matter its potential for playing with lives of people humongous as every stakeholder is suitably taken care of  (bribed/enriched) and in the ambiance of total collusion people are made to suffer. Nevertheless, hoping for the best people expect that revamp of drug regulators will go a long way in ironing out deficiency in the system and help Indian pharms rise to the world standards!

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