Physician Agency Seeking Withdrawal of Compulsory Prescriptions for Generic Drugs

Physician Agency Seeking Withdrawal of Compulsory Prescriptions for Generic Drugs

The new rules say all doctors must prescribe generic drugs, otherwise they will be penalized.

New Delhi:

IMA has written to the Union Health Minister Mansukh Mandaviya requesting the repeal of the National Medical Commission (NMC) regulation on mandatory prescribing of generic drugs until there is quality assurance of all medicines.

The physicians’ body also expressed concern over regulations barring doctors from attending conferences sponsored by pharmaceutical companies and said the ban needed reconsideration. They demanded that associations and organizations be excluded from the scope of the NMC regulations.

Members of the Indian Medical Association and Indian Pharmaceutical Alliance had on Monday met Health Minister Mandaviya and expressed their concerns over the NMC regulations.

The National Medical Commission (NMC) in its ‘Regulations relating to the Professional Conduct of Registered Medical Practitioners’ states that all doctors must prescribe generic drugs, otherwise they will be subject to sanctions and their license to practice may also be suspended for a certain period of time.

He also asked doctors to avoid prescribing brand-name generic drugs. “This is a matter of great concern to IMA because it has a direct impact on patient care and safety. It is believed that less than 1 percent of generic drugs manufactured in India have been quality tested. Patient care and safety are non-negotiable for the two, the government says. and the medical profession,” the IMA said in its letter.

The quality assurance mechanism in our country is very weak, the association said.

India has more than 3 lakh batches of 70,000 drug formulations, the quality assurance mechanism in our country can ensure quality control of only 15753 drugs annually, he said.

“By 2023, only about 12,000 tests will be carried out by the CDSCO and the State Department of Drug Control simultaneously. If we consider one sample from each batch tested, the minimum number of tests required is around 3,00,000,” said the IMA.

According to NMC regulations, “Registered medical practitioners and their families may not accept gifts, travel amenities, hospitality, cash or monetary grants… access to entertainment or recreation from pharmaceutical companies or their representatives, commercial healthcare companies, medical device companies. , or a company hospital under any pretext.”

In addition, registered medical practitioners may not engage in third-party educational activities such as seminars, workshops, symposiums and conferences, which involve direct or indirect sponsorship from pharmaceutical companies or related health sectors, the regulation states.

In this regard, the IMA said that while the intent to ensure ethical behavior and an impartial learning environment is legitimate, an outright ban on third-party educational activities sponsored by pharmaceutical companies or the health-related sector “requires thoughtful reconsideration”.

Rather than assuming that sponsorship influences the educational process, the focus should be on ensuring transparent and impartial presentation, thereby enabling health professionals to make informed judgments.

IMA asked the government to allow professional associations to use pharmaceutical funds for CME and educational/research activities in a transparent and bona fide manner.

In addition, NMC regulations also prohibit physicians from advertising any brand of medicine, medicine and equipment or advertising them. In this regard, the association said the IMA and many professional organizations are registered under the Societies Act or similar laws.

The IMA clearly stated its object in its memorandum to regulate and comply with laws on medical education and public health. Its capacity to conduct continuing medical education and health awareness campaigns flows right from the point.

“Legally entitled and authorized to raise funds for these activities. As long as the funds are collected in a transparent, bona fide manner, and are used for association objects, IMA is still within its legal rights,” said IMA.

“This amendment makes the concept of mutuality redundant in terms of transactions between associations and their members or vice versa. The relationship between members and the former association was treated as a win-win transaction and there were no taxes in the pre-GST era. Now. any transaction between the association and its members will be carried out between different persons, i.e. the association on the one hand as individuals and the members on the other. If this transaction is carried out it will be taxed under GST,” he said in the letter.

The government cannot treat associations and their members as different people under GST and one and the same person under NMC, he said.

Regarding the NMC stating that within 3 years from the issuance date of this regulation, registered medical practitioners must ensure fully digitized records, comply with the provisions of the IT Act, data protection and privacy laws, the IMA said that “while the idea of ​​digitization is welcome , and mandating that this has to be done within 3 years is unrealistic”.

The regulation should allow for a gradual transition. Additionally, there are valid counter-arguments against EMR such as loss of quality patient time, eye contact, etc. Media and documentation platforms should be left to doctors, he said.

(Except for the title, this story has not been edited by NDTV staff and published from a syndicated feed.)

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