Indian Academy of Pediatrics
Secretariat: Kamdhenu Business Bay, 5th Floor, Plot No. 51, Sector 1, Juinagar, (Near Juinagar Railway Station), Nerul, Navi Mumbai – 400706 (India)
Phone (022) 27710857, 27715578
Email: centraloffice@iapindia.org Website: http://www.iapindia.org
Dr Upendra S Kinjawadekar President, IAP 2023
Email: president@iapindia.org Mobile: 9821186601
To,
Shri Mansukh Mandviya
Honorable Minister
Minister of Health & Family Welfare Government of India
New Delhi
Dear Sir,
Dr Vineet K Saxena
Hon. Secretary General, IAP 2022 & 23 Email: secretary@iapindia.org
Mobile: 9837024621
August 21, 2023
Subject: Indian Academy of Pediatrics’ concerns about the adverse impact of some of the NMC regulations
Indian Academy of Pediatrics is apex body of about 42,000 Pediatricians of India which mainly works for their Academic up gradation with an aim to improve standards of Child Health by running various Action Plans through its 30 State and 329 District Branches. It also runs and supports various programs with huge social impact like Neonatal Resuscitation Training Program, World Breastfeeding Week Celebration, Adolescent Week, Advance Life Support (ALS) and Basic Life Support (BLS) courses for masses, rational antibiotic prescription practices etc. to reduce Neonatal Mortality and under Five Child deaths and improve child health from 0-18 years. Through Sankalp: Sampoorna Swasthya IAP is committed to reach school students across the country for the prevention of non-communicable diseases.
IAP appreciates the noble intentions of the GOI that the patients should get medicines at cheapest prices. We stand in support of affordable and rationale treatment and ethical practices by RMPs which NMC regulations aim at.
But at the same time we have major concerns about the potential adverse impact on the child health due to the regulation which makes prescribing Generic drug mandatory.
Let us put forward IAPs viewpoint on this serious issue systematically –
1- If RMP s are allowed to prescribe only Generic drugs, then what is going to happen to the huge stocks of Branded drugs which are continuously being added every day in the numerous factories all over India?
2- Will the several lac of Medical stores allowed to stock and sell Branded drugs?
3- If yes, then will the medical store substitute the generic medicine by the branded medicine by the RMP?
4- If yes, the whole objective of the GOI will fail. How are the regulatory authorities going to make sure that no
branded medicine is sold by any Medical Store?
5- If no Branded drug is allowed to be sold, why not the licenses of the Pharmaceutical companies who
manufacture these branded drugs, being terminated?
6- There is a general understanding that branded drug is superior in quality and thus efficacy to its generic
counterpart. How is the Government going to ensure that every generic medicine carries equal efficacy and
quality as branded one?
7- If the Government has some quality control plan of generic medicines, it should be disclosed and if not, then this
regulation should be suspended till strict quality control of generic medicines is ensured. ….2….

…2….
8- If the Government is of the view that no patient should purchase branded medicines, does it hold similar view for customers purchasing different branded items like clothes, cars etc., though they are for the sake of mere luxury while a branded antibiotic vs. generic antibiotic can be a matter of life and death for the parents of their child.
In view of the above serious concerns, IAP has following important suggestions to make –

1. RMPs should be allowed to write both the branded & generic names of the medicines on their prescription so that the patient has a choice to purchase branded or generic medicines.
2. If Government wants to abolish sale of branded medicines, it should terminate the licenses of Pharmaceutical companies to manufacture same drug under hundreds of brand names.
3. If the Government wants to switch totally to generic medicines it should ensure strict quality control system in place first so that both Doctors and patients can have enough confidence on them.
   As regards to point no 35 of the notification which says
   ‘RMPs should not be involved in any third-party educational activity like CPD, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector’
   There should be clarity in defining the third party as well as the allied health sector. As stated above, IAP does its educational and community awareness activities in collaboration with many agencies like UNICEF/WHO and is registered under the charity commissioner.
   Despite Doctors not being part of the multibillion pharmaceutical industries in any manner, they are unfairly targeted for its fallacies which is highly unfortunate and painful. If anyone who is as deeply concerned for the wellbeing of their child as his/her parent, it is the treating Pediatrician. So on behalf of whole of Pediatrician community of this country, IAP requests you to make necessary amendments to the regulations in the best interest of the health of the children and people of this country.
   With Kind Regards
   Yours Sincerely
   For Indian Academy of Pediatrics
   Dr Upendra Kinjawadekar Dr Vineet K Saxena
   President, IAP 2023 Honorable Secretary General IAP 2022 & 2023