IMA writes to Mandaviya, seeks withdrawal of generic drugs mandate

"It is a matter of great concern for IMA since this directly impacts patient care and safety. It is believed that less than 1% of the generic drugs manufactured in India are tested for quality"

The IMA has written to Union Health Minister Mansukh Mandaviya seeking withdrawal of National Medical Commission (NMC) regulations on mandatory prescription of generic drugs till there is quality assurance of all medicines.

The doctors' body also expressed concern over the regulations which bar doctors from attending conferences sponsored by pharma companies saying such a prohibition warrants reconsideration. It demanded associations and organisations should be exempted from the purview of NMC regulations.

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

The National Medical Commission (NMC) in its 'Regulations relating to Professional Conduct of Registered Medical Practitioners' stated that all doctors must prescribe generic drugs, failing which they will be penalised and their licence to practice may also be suspended for a period.

 

It also asked doctors to avoid prescribing branded generic drugs.

"It is a matter of great concern for IMA since this directly impacts patient care and safety. It is believed that less than 1 percent of the generic drugs manufactured in India are tested for quality. Patient care and safety are nonnegotiable for both, the government and the medical profession," the IMA said in its letter.

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

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

"In 2023, only around 12000 tests were conducted by CDSCO and State Drug Control Department together. If we consider one sample from each batch is tested, the minimum required number of tests was around 3,00,000," the IMA stated.

According to the NMC regulations, "Registered medical practitioners and their families must not receive any gifts, travel facilities, hospitality, cash or monetary grants... access to entertainment or recreation from pharmaceutical companies or their representatives, commercial healthcare establishments, medical device companies, or corporate hospitals under any pretext."

Also, registered medical practitioners should not be involved in any third-party educational activity like seminar, workshop, symposia and conference, which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector, the regulations stated.

On this, the IMA said that while the intention to ensure ethical conduct and unbiased learning environments is valid, an outright prohibition on third-party educational activities sponsored by pharmaceutical companies or the allied health sector "warrants thoughtful reconsideration".

Rather than assuming that sponsorships affect the educational process, the focus should be on ensuring transparent and unbiased presentations, enabling healthcare professionals to make informed judgments.

The IMA requested the government to allow professional associations to use pharma funding for CMEs and educational/research activities in a transparent and bona fide manner.

Besides, the NMC regulations also prohibit doctors from endorsing any drug brands, medicine and equipment or advertise them.

Regarding this, the association said the IMA and many professional organisations are registered under Societies Act or similar acts.

The IMA has clearly stated objects in its memorandum that rules and bye laws regarding medical education and public health. Its capacity to conduct continuing medical education and health awareness campaigns flows directly from its objects.

"It is legally eligible and empowered to raise funds for such activities. So long as the funds are raised transparently in a bona fide manner and are used for the objects of the Association IMA is within its legal rights," the IMA said.

"This amendment makes concept of mutuality redundant in the case of transactions between association with its members or vice versa. The relationship between the members and the association was previously treated as mutual benefit transactions and there was no tax in the pre-GST era. Now any transaction between an association and its members will be between distinct person i.e., association on one hand as person and members on the other side. If this transaction is supply it will be taxable under GST," it said in the letter.

The government cannot treat the association and the members as different persons under GST and one and the same under NMC, it stated.

On the NMC stating that within 3 years from the date of publication of these regulations, the registered medical practitioners shall ensure fully digitised records, abiding by the provisions of the IT Act, data protection and privacy laws, the IMA said that "though the idea of digitalisation is welcome, mandating that this should be done in 3 years is unrealistic".

The regulations should allow for gradual transition. Moreover, there are valid counter arguments against EMR like loss of quality patient time, eye contact etc the medium and platform of documentation should be left to the doctor, it said.