Both these actions come under the purview of the Drugs and Cosmetics Act 1945 as well as various other laws like the IMC Act 1956, the Pharmacy Act 1948 and the National Pharmaceutical Pricing Authority. Currently there is a great deal of turmoil particularly with the Drugs and Cosmetics Act; the most recent being in the State of Haryana which passed an amendment to this Central act permitting graduates of Ayurveda to prescribe allopathic drugs. A similar rule in Maharashtra has been challenged by a writ petition and the matter is in court. The amendment is being justified on the grounds that allopathic doctors are reluctant to serve in the rural areas. This argument (of doctors being unwilling to serve in rural areas) has been junked by the example of Kerala, where the issue was resolved by simply improving the working conditions in the rural areas. Ignored is the fact that the various Indian systems of medicine and allopathy have their own individual philosophies on which therapies are based and are therefore as incompatible as oil and water
A second area of concern is the explosion of internet pharmacies in India, currently numbering about 50 and all functioning without any regulatory control. On the one hand e-pharmacy does have benefits. It would be a boon for the elderly and those confined to the house, to go online and have their medication delivered to the house, particularly drugs for long term treatment. Long queues are avoided, payments are convenient and drugs could be cheaper because retailer margins are eliminated. However there are objections based on the international experience. Internet pharmacies are a known source of illegal recreational drugs, spurious drugs and stolen drugs. There is also the risk of prescription abuse by using the same prescription numerous times. India has acquired the dubious reputation of being the world’s largest source of spurious drugs as recorded by customs seizures.
The US FDA in response to an online order in a test case received an envelope with an India postmark with some unlabeled white tablets which on analysis bore no resemblance to what was ordered. Recent data released by the Swiss government indicated that India accounted for 42% of all confiscated drugs. These included the so-called erectile stimulants, sleeping tablets, weight reducing tablets tranquillizers and other prescription only medicines. Without a specific law along the lines of the US “Ryan Haight Act” there are tremendous dangers in permitting this trade. Self-medication will increase, resulting in misuse. Quality control will disappear; inappropriately stored drugs like insulin, expired drugs, counterfeit and even harmful adulteration will wreak havoc. The use of recreational and addictive drugs will explode. Quackery will flourish with outlandish claims of miracle cures.
A third area of concern is the one highlighted by the Director, FDA recently, namely Schedule K of the Drugs and Cosmetics Act. This schedule, granted the physician the privilege of stocking and dispensing drugs to his own patients, provided he did not run an open shop, sell over the counter, or engage in the sale, manufacture import or distribution of drugs. This exemption was provided to deal with the dearth of pharmacies in remote areas at that time. Today, the scenario has changed with ever increasing availability of chemists, even in rural areas. Hence in the context of medical practice today, though the exemption of RMP’s from obtaining a licence to dispense drugs to his own patients still continues, two critical issues need to be addressed. The exemption is subject to the physician maintaining records of purchase and dispensing, particularly the batch number, expiry date and details of the patient. This provision is a safeguard in the event of an unfortunate side effect of the drug. The drug can be tracked from manufacturer to every patient to verify quality and protect other patients.
Hospitals and Nursing homes were never meant to be included in this Schedule K exemption provision and therefore by law, all hospitals and Nursing Homes, however small or big are required to obtain a drugs license for running a pharmacy within their hospital / nursing home establishment. However the FDA authorities are dismayed at the manner in which many hospital-run pharmacies without a licence totally flouting the provisions of the Pharmacy Act which stipulates that a qualified pharmacist should be present at all times that the pharmacy is open, in addition to other parameters like the floor space etc. Other rules pertaining to maintaining records of purchase and sale also continue to prevail on these establishments. The Director FDA stated that his Directorate was not on a fault finding mission to detect and deal with the non-complying Hospitals / Nursing homes, but on a mission to increase awareness of the existing laws by all concerned and ensure compliance in the interests of the good of the general community in an amicable and time bound manner.
Finally the MCI is set to notify the new ethical guidelines under the IMC Professional Conduct Etiquette and Ethics (Amendment) Regulations 2015. These guidelines define the punishment for errant doctors who accept freebies from pharma companies for prescribing their products. The punishment is based on the amount of gratification and ranges from censure to removal of the name from the register for varying periods depending on the quantum of gratification received. No doctor can practice without a valid registration with the Medical council. Doctors have attempted to hide behind the euphemistic label of costs for research in accepting such bribes. However all research is now regulated by appropriate scientific bodies such as the ICMR. That the MCI itself has come in for severe criticism in the Parliamentary Standing Committee Report submitted is quite another matter to be looked at separately. At the end of the day it all comes down to the larger interest of the patient safety and their accessibility to safe and efficacious drugs.
(Dr Gladstone D’Costa is the Chairman, Accreditation Committee and member, Executive Committee, Goa Medical Council.)
