On the 21st January 2013, the Medical Council of India drew attention to Section 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 which states “Every physician should as far as possible, prescribe drugs with generic names ”. Registered medical practitioners were directed to comply with the regulations without fail. In response, the Indian Medical Association held a meeting on this issue on the 6th February, 2013 with all relevant stakeholders. Two of the salient decisions were: The Government of India should undertake measures to strengthen the monitoring system of medicines for quality control of all batches of drugs and the so-called nexus between doctor and chemist/pharma company, where a doctor writes a particular expensive brand or one available only with particular chemists should be considered unethical. The Goa Medical Council has been issuing free of cost a booklet “Prescription Guidelines” to all fresh medical graduates on registration since 2012.
History repeats itself. On 21st April, 2017 the MCI issued the following circular as a follow-up to a 2016 circular: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he / she shall ensure that there is a rational prescription and use of drugs” and warned of “suitable disciplinary action” by the SMC/MCI. This followed the PM’s Surat reference to the “Pradhan Mantri Bharatiya Janaushadhi Pariyojana” which aims to provide a legal framework to ensure that doctors prescribe drugs with generic names so as to reduce costs for patients. Meetings and objections followed as before; AIIMS reported only 230 generic medicines available in its stores.
Drugs can be identified by the brand/trade name assigned by the manufacturer; a generic name; and the chemical name. For example Crocin, is the trade name, Paracetamol, the generic name, and Acetaminophen {or N-(4-Hydroxyphenyl) acetamide}, the chemical name. The debate arises because the use of particular trade names may be associated with increased costs, and/or vested interests on part of the doctor who assumes the role of company agent in return for freebies and “holidays”.
Legal opinion suggests that there is no material difference in the two circulars; in the recent circular the expression “as far as possible” has been dropped. It made no sense in the first place. The circular uses the word “should” stimulating the debate on whether this is recommendatory or mandatory. But more important, is the concern over quality control. The directive presumes that the pharmacist will indeed provide a cheaper drug with quality assurance. Both presumptions are flawed. The pharmacist will be swayed a margin incentive and quality control is non-existent in India.
The UK has a Medicines & Healthcare Products Regulatory Agency (MHRA) which proactively checks all the manufacturing processes, and operates a quality surveillance system to sample and test medicines. In the USA, the FDA ensures the quality of drugs by monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations which ensure that a product is safe for use and that it has the ingredients and strength it claims to have. The FDA can issue warning letters or initiate punitive action against a company that fails to comply. It even inspects manufacturing processes in countries whose products are exported to the US. There is no comparable mechanism in India.
The Central Drugs Standards Control Organisation (CDSCO) has neither the manpower nor material to verify manufacturing processes of companies or the capacity to proactively check drug quality. 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/staffed, while the others were poorly staffed and did not even have the bare minimum equipment” – Mashelkar Report.
“Partnership for Safe Medicines” and “ASSOCHAM” have produced alarming statistics. Around 25% of medicines in developing countries are counterfeit. 60% of these have no active ingredients; 17% have inaccurate doses of correct ingredients and 16% have incorrect ingredients. India’s Union Health Ministry admits that 5% of drugs in India, worth over Rs 5000 crores are substandard. Independent experts, including the WHO, quote figures that go up to 25%. A BBC undercover documentary revealed that there is a thriving counterfeit industry in India. How much one pays for a particular batch of fake medicines depends on the degree of adulteration, which can be customised to range from 0 to 50%. Presumably purity above this makes the trade economically unviable!
There is confusion in the very terms “spurious”, “misbranded”, “adulterated”, and “counterfeit”. This is reflected in the interpretation of available statistics quoted by reputed bodies such as the WHO and the Union Health Ministry. Studies conducted by SEAR Pharm, with WHO (SEARO) as well as the CDSCO have shown that quality assurance is better with branded products. Remedial measures are available, but never implemented. A system of bar coding of products, radio-frequency identification, electronic pedigree and Raman Spectroscopy have all been considered and abandoned over the question on who would bear the added costs.. The system of SMS information is particularly cost effective and attractive. A doctor prescribes by generic or brand name; the patient or the pharmacy SMSes the name to a particular number and receives a list of options with the price. The patient is then able to make an informed decision.
(The writer is a founder member of the Voluntary Health Association of Goa)
