The rampant malpractice in the pharmaceutical drugs industry of offering freebies to doctors was described as a serious issue by the Supreme Court, on August 18.
The apex court’s observation came in response to a petition that said the Central Board of Direct Taxes (CBDT) had accused the makers of Dolo-650 of distributing freebies worth Rs 1,000 crore to doctors as consideration for prescribing the tablet.
In its petition, the Federation of Medical & Sales Representatives Association of India (FMRAI) also claimed that it was only a tip of the multi-billion unethical iceberg.
When a Bench headed by Justice DY Chandrachud was informed that the drug was prescribed to millions during Covid-19 pandemic unethically, he remarked: “This is not music to my ears. I was also asked to have the same when I had COVID.
This is a serious issue and matter.” On being told that an overdose of the drug could have an adverse effect on liver and kidney, the court sought a response from the Centre and asked the petitioner FMRAI to file its counter-affidavit within a week of the Centre’s reply.
Significantly, the PIL claimed that Dolo-650 being unethically prescribed to patients during the pandemic is just the latest example of drug companies’ malpractices. The case is likely to open a can of worms. The 650 mg anti-inflammatory, fever- reducer Dolo tablet is among a myriad of drugs that ‘obliged’ doctors prescribe to patients in exchange for a variety of gifts they receive from the drug companies.
According to FMRAI, the malpractice is an open secret. It told the court that it is prepared to submit a long list of such malpractices after the Centre’s response to its notice. The modus operandi is ingenious.
While the market price of the drug up to 500 mg is regulated, the dosage beyond 500 mg can be priced at the will of the manufacturer. Thus the same drug with 650 mg dosage is priced almost three times the price the drug with 500 mg dosage.
Doctors prescribed Dolo-650 to patients during the pandemic three times a day, even though there is no evidence that a higher dose is more effective. This underlines a basic flaw in drug regulation mechanism in the country.
There are several laws and regulations enacted between 1955 and 1986 to regulate the manufacture, sale and distribution of drugs. While the Drugs and Cosmetics Act, 1940, regulates the manufacture, sale and distribution of drugs, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955, and the Consumer Protection Act, 1986, are also in place. However, there is no law regulating the marketing and promotion of pharmaceutical companies.
A doctor’s licence can be revoked for malpractice because of his/her relationship with a pharmaceutical firm. However, drug firms that abet the malpractice are exempt from the purview of the law.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) regulation was brought in 2002. Doctors getting gifts, travel facilities, cash or other monetary benefits from pharmaceutical companies are prohibited under this regulation. Ironically, while the doctors have occasionally been subject to litigation and penalty for violating this code of ethics, the pharmaceutical firms that tend to bribe them get away scot-free.