Tackling the 'triumvirate'

The National Medical Commission (NMC), a few days ago, stayed the operation of the new 'Registered Medical Practitioner (Professional Conduct) Regulations 2023' which mandated prescription of generic drugs. The new regulation was a thoughtful intervention by the government, as it was meant to lower the healthcare costs for the common man since the generic drugs are cheaper up to 80 per cent vis-à-vis the branded ones. The socialist philosophy behind the reform was also evident, for it meant to tackle the rampant profiteering tendency prevailing in the healthcare sector, fuelled by a symbiotic nexus among the pharmaceutical firms, the medical practitioners, and the pharmacists — the ‘triumvirate' of healthcare, practically. But apparently, the vehement opposition by the three key players seems to be one of the reasons for putting the patient-friendly new regulations on hold.

The Indian Medical Association (IMA) contended that the new regulation compromises on comprehensive medical care and dents the autonomy of doctors. But the fact that India happens to be the largest supplier of generic medicines to the world, with 60,000 different generic brands across 60 therapeutic categories, demolishes the first part of the argument while the second part i.e., 'autonomy', is preposterous, for what is at stake is the life of the patient and not that of the doctor. The instant discomfiture is only a tip of the iceberg pointing to serious issues involved in healthcare, such as drug safety, pricing, data disclosure, cost effectiveness of treatments, basic rights of patients etc., not to mention drug counterfeiting and pharmaceutical frauds.

American journalist Katherine Eban, in her best seller 'Bottle of Lies' exposes the unethical practices such as fake trials, fabricated reports and institutional fraud in Indian pharmaceutical companies. She reveals that 100 per cent of dossiers submitted to Indian regulators for approval by Ranbaxy were fake in comparison to 50-60 per cent in the US and Europe. She states that the pharma sector is thriving not by ground-breaking research but by fraud. However, she also juxtaposes Hamied (Cipla Inc.), famous Indian scientist known as the Robinhood of the pharma sector, as the ideal pharmaceutical producer for revolutionising generic drug manufacturing globally, saving millions of lives.

The Pharma sector may frown upon her findings but the conduct of many pharmaceutical firms with regard to formulation of drugs, pricing and strategic promotion has been controversial, involving dubious business practices in collusion with doctors, pharmacists, and sometimes scientists too, with mutually rewarding deals. In 2022, a controversy surfaced when a PIL was filed by the Federation of Medical and Sales Representatives Association, India (FMRAI) in the Supreme Court on a disclosure by the CBDT that freebies worth Rs 1,000 crore were given to doctors in the name of scientific and academic promotion by Micro Labs inc. — the producer of DOLO-650 (popular during the pandemic). Though it was ascertained later that the figure was exaggerated, the Supreme Court expressed serious concern and directed the state to file a reply. While the medical practitioners are governed by the (Professional Conduct, Etiquette and Ethics) Regulations, 2002, the pharma companies are governed by the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), and the pharmacists by Pharmacy Practice Regulations, 2015. But none of the above seem to break the nexus of the trio.

The government, usually by nature, leaves no stone unturned in restraining the healthcare industry from unethical practices, since public health and security of citizens' lives are matters too sensitive to ignore. For example, the claims of deduction by Pharma companies against huge expenses incurred on freebies and on seminars in the name of CME are no longer permitted in tax assessment now. The instant regulation on generics, for that matter, itself vouches for the government's commitment to affordable and accessible healthcare to all. However, the problem is too complex to be set to rest by state action alone. Despite numerous laws and regulations, the culprits go scot-free taking advantage of the loopholes in the system. The (Professional Conduct, Etiquette and Ethics) Regulations, 2002, stipulate that acceptance of freebies and gifts may result in suspension of licences to practice medicine. But hardly any doctor’s licence has been suspended till now. While legal action under the Drugs and Cosmetics Act/ Prevention of Corruption Act/Consumer Protection Act is a long-drawn process, illiteracy and poverty in the society vitiate the course of justice.

Unlike the other sectors of the economy, healthcare is a delicate subject of governance involving life and death consequences. Moreover, advancement in medicine with super specialities led to a monopolistic trend in treatments for certain ailments. The more expensive a treatment is, the more it is in demand, irrespective of affordability. A socialistic solution like state control on the healthcare market is unthinkable in a free economy any more than a crackdown on the medical mafia, for it may result in sudden and large-scale disruption of essential services, impacting the society. We need a cautious approach with a comprehensive framework, building trust and ensuring cooperation from all the stakeholders to address the issues.

To begin with, a charter of Rights of Patients in tune with basic right to life and liberty (Article 21) is necessary to ensure transparency and accountability. In 2018, the MoHFW circulated 'Charter of Patients' Rights' drafted by NHRC, and invited suggestions. There were 17 rights including right to information on treatment, right to obtain records, right to consent, right to transparency in rates, right to second opinion, right to choose pharmacy for drugs etc. If the charter comes into operation, it will empower the patients and will work as a deterrent against extortion. Secondly, the UCPMP, which is voluntary now, needs statutory teeth in order to tighten the grip on the pharmaceutical sector. Thirdly and most importantly, it is necessary to constitute a dedicated healthcare regulator, like in many advanced countries. Revitalising the existing regulatory bodies, focussing on accessibility, quality standards, pricing and cost containment can be the best alternatives in the meantime.

A study on pharmacists in India by Basak SC and Sathyanarayana D (Indian J Pharm Sci. 2012;74(6):571–5.) finds that the majority of pharmacists (80 per cent) are against generic drugs; pharmacists can play a vital role, for they have a lawful right to provide counselling to patients and substitute generic drugs for branded ones. Regarding medical practitioners, it is also true that barring a few established 'dynasty doctors', the majority of struggling practitioners depend on pharma companies for CME through quality seminars — the 'freebies' which the state-run or other institutions can hardly provide. Such medical practitioners need state support and encouragement. Proper incentives can help forge a healthy partnership between the doctors and pharmacists to resist the enticing influence of pharma companies. Finally, a strong public awareness is necessary to prevent the medical fraternity from drifting away from their sacred obligation to society and the nation.

The writer is a former Addl. Chief Secretary of Chhattisgarh. Views expressed are personal