Rules and regulations for new healthcare Innovations in India

Here are some points i found out after a very deep research on certifications of healthcare products. A lot of investor pitches i went to the investors asked if ZINI.ai has been approved or certified by a regulatory body. So here is what i found out after some extensive research. 

This may be helpful to #startups as well as #investors. Specially investors who may have been told by some #startup that they are certified. 

1. There is no regulatory body like the FDA that approves new technologies, softwares or solutions in India for the healthcare sector. No official body has been made or setup so far that can endorse or certify new inventions or processes in medicine or healthcare.

2. There is a body that passes or approves medical equipments or hardware. But only hardware not software.

3. Legally as per the law and ethics code of conduct, IMA or any doctor individually is not allowed to endorse or recommend commercial products. 

4. They can however recommend constituent chemicals or constituents e.g proteins but not 'WHEY protein'.

5. They can at max provide reviews and their opinions on these items but as in a non commercial way.

6. All these advertisements by KENT water purifier or other companies like PepsiCo saying 'Recommended by IMA' are commercial deals with IMA after paying the IMA more than 50 Lakh + and above in many such deals (source: internet). But all these deals have been objected by multiple bodies and individual doctors country wide and court cases are in process. The law says IMA and MCI are not allowed to endorse or recommend any commercial product by taking money.

6. The worst that happens in such cases is that 

a. the company has to remove the IMA recommended tag 

b. The IMA stops endorsing the company 

c. The money paid to IMA is lost and

d. The doctors who endorsed or signed the deal may temporarily or permanently loose their license and have to undergo some unwanted harassment.

So here is what i found out in my study on various regulations and laws so far in our country.

I do not claim that this is 100% correct as i also used a lot of online resources to gather this info and they may not always be accurate. But from what i studied, this is what seems to be the case.

If you have any improvements or corrections for this, do post in the comments.

You can also share your views on these laws.

Thank you.