Assured Quality ‘Must’ For Generics

New Delhi: The National Medical Commission (NMC) recently halted the mandate for doctors to prescribe only generic drugs or face punishment, after facing flak from doctors, industry, and allied associations.

Industry experts delve deeper and denote that NMC needs to make sure that generic medicines are of the same quality as their branded counterparts, gain the confidence of doctors, and set the right expectations.

Speaking to ETHealthworld, Prof (Dr) YK Gupta, President, AIIMSVijaynagar and Jammu, said, “Generic medicines should be of assured quality, and for that, there should be a system. Once this is done, the second step should be for doctors to have the confidence to prescribe generics. This will happen gradually; once doctors develop faith, they will not be reluctant to prescribe generic medicines, and prescribing is a doctor’s choice. In general healthcare professionals are showing reservations, but these reservations will go away once confidence in generic medicine increases.

Meanwhile, Suresh Pattathil, Chairman, OPPI, said, “As far as generic medicines are concerned, we believe that healthcare professionals (HCPs) should have the authority to prescribe medication since they possess the necessary knowledge to make the best decisions for patients. We often associate high quality with well-known pharmaceutical companies. If a generic product is prescribed, it is essential to know the manufacturer’s reputation. We suggest that patients should have access to generic alternatives from reputable companies.”

Commenting on the call for a ban on all irrational fixed-dose combinations (FDCs) by the Alliance of Doctors for Ethical Healthcare (ADEH), Gupta said, “FDCs are always not bad, but there are some fixed-dose combinations that are irrelevant and they’re not rational, and sometimes maybe even harmful. Those must not be promoted by mistake; if they have been introduced into the market, it is the responsibility of the doctors not to prescribe or promote them again.However, not all fixed-dose combinations are bad. There are certain combinations like antihypertensive drugs, anti-diabetic drugs, some antibiotics, and global clinic acid and amoxicillin; these are rational FDCs, and anti-HIV drugs are rational combinations, but if an antibiotic is combined with an analgesic and also add to it the vitamin component, it is an absolute combination. If you add an analgesic with vitamins and anything of an herbal nature, which is not relevant it is an irrational combination. Therefore, this must be avoided.”

Sharing his views on FDCs, Pattathil said, “The widespread use of fixed dose  combinations (FDCs) and the potential shift to generics present practical challenges. Doctors may find it cumbersome to include multiple molecule names in a prescription. Transitioning to digital prescriptions is a potential solution, but it must also cater to remote areas, not just developed cities. Quality assurance is vital, and companies will hesitate to invest in maintaining quality if they fear that their brands may not sell well. India primarily operates as a branded generic market, and shifting entirely to generics could have significant impacts on the pharmaceutical industry and the quality of medications available.”

He also added that investments in public awareness and collaboration with medical bodies are crucial, especially for diseases like glaucoma, hypertension, and diabetes, where many patients remain undiagnosed or untreated. These efforts cannot solely rely on pharmaceutical companies and require collaboration with medical societies. Restricting such collaborations could hinder patient care.

“There is a need for a comprehensive and balanced approach that aligns the NMC regulations with international guidelines and involves stakeholder consultations. India’s pharmaceutical industry should continue to maintain high-quality standards to ensure the safety and efficacy of medications in the country,” concluded Pattathil.

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