Dr Suresh Saravdekar, Medical Consultant (procurement for Pharmaceutical and Medical devices) Municipal Corporation of Greater Mumbai, in a tête-à-tête with Raelene Kambli, points out that India needs a single healthcare policy to resolve its concerns revolving around affordability, accessibility and quality
Doctor, you have worked with some of the well-known public hospitals in Maharashtra. Can you tell us about your observations on the quality of medical devices used at these hospitals?
Medical devices are mainly classified into three categories. The first is high-end medical equipment such as MRI, CT scanners, X-ray machines, cath lab equipment etc. The second category is OT equipment and surgical instruments and the third is devices such as catheters, IV sets etc.
Before 2005, manufacturers of medical devices enjoyed free import duty. However, in 2005, it came to light that some material, devices and stents were brought to JJ Hospital for clinical trials without prior permission and import licenses for those products. Consequently, the FDA seized those medical devices and stopped all clinical trials at the hospital. This case highlighted the need for regulation in this area and the government released the first circular in 2005 stating compulsory import license for medical devices. Under this circular, only four to five medical and surgical devices such as catheters and IV sets would get free import license but they required a Form 10 issued by The Central Drug Standards and Control Organization (CDSCO).
Currently, at government hospitals, medical devices used are of good quality. Especially, when it comes to radiology and OT equipment. Moreover, there are only few MNC companies that manufacture these high-end products which is why there is less choice as well. In the second category of medical devices like stents, heart valves etc., till 2010 the market was dominated by multinationals such as Medtronics, Abbott, Boston Scientific, and some more. But now there are some Indian manufacturers of stents as well. However, doctors still prescribe stents made by multinationals, even at government hospitals, as the indigenous ones do not have US FDA approvals.
What is your opinion regarding the quality of medicines?
Where medicines are concerned, I would like to cite examples from the Parliamentary report published in 2012 on the functioning of the CDSCO. The examples highlight how drugs are being brought into India without conducting clinical trials. This is happening because in India, we have two FDAs, one handled by the central government that takes care of making policies and the state FDA that provides licenses to drugs. Which is why there are so many loopholes. For example, say a drug that is declared sub-standard in Maharashtra is sold in Kerala and other states where they get easy approval. The worst part is that there is no proper data available on these subjects.
So, do you think India requires centralised control for drug licensing?
Yes. I completely agree that India requires centralised and more co-ordinated control where a high level of transparency is maintained. In 2012, the Parliamentary report did call for centralised control and the same was repeated in 2013 as well but no work has been done in this area.
I feel the main reason for no improvement in this area is because our healthcare, drug and medical device policies are very pro-industry and not pro-health. This is the reason why pharma policies are put under the Ministry of Chemical and fertilizers while the healthcare delivery segment falls under the Ministry of Health and Family Welfare. In contrast to this, world over, economies have healthcare and pharma industry work in tandem with each other and are covered under one standardised health system. But here in India, pharma and healthcare sectors have no co-relation. They function on parallel tracks.
Recently, Union Minister for Chemicals and Fertilisers, Ananth Kumar announced that the government will establish a separate ministry for pharma and medical devices sector in the next one year. What is your opinion on this move?
I don’t think this move will help to improve our current system. I feel that this dual policy system only disrupts the co-ordination between the sectors. Healthcare and pharma sectors should work in sync with each other. Instead of making a separate ministry for pharma and medical devices, these two industries should be covered under the Ministry of Health.
What is your opinion about the drug procurement process in hospitals? How can it be utilised to provide quality services?
The problem with drug procurement agencies within both the government and private hospitals is that this responsibility is given to doctors who are not well versed with laws and implications of the licenses. So, there is a need to educate these procurement agencies within hospitals. Moreover, there is a need to also introduce filters in the drug procurement process within hospitals just like the system which has been introduced in Maharashtra. We have made WHO certification compulsory for companies. If they do not comply with these norms, their drugs will be rejected at once. This helps us ensure quality supply of medicines to our patients.
Public hospitals characteristically train future physicians. What measures can be incorporated into training programmes by public hospitals to improve the quality of services provided by the physicians?
Training is the best solution in this regard. Also, our medical education for doctors should also cover areas of pharmacy so that they have a better understanding of drug quality, licensing policies and the laws around it.
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