• What motivated you to establish “Peninsula Polymers ( Penpol ) ”. What are the challenges and obstacles you faced during the establishment of your company?

I had decided to quit my government job, and was looking for a suitable opportunity. At that time I came across an announcement in the press about blood bag manufacturing technology developed by Sree Chitra Tirunal Institute. I visited the Institute and after discussions decided that this was what I wanted to do.

• Can you please chart your journey so far highlighting the major turning points?

Since the technology was a lab-scale one, we had to face many problems in scaling it up to commercial scale. This naturally extended the gestation period, and led to heavy losses. However, this also enabled us to learn (the hard way!) many aspects of the technology we would otherwise have not learned. Dumping by foreign competitors almost forced us to close our plant, but we managed to stay in the market, and with the support of the Govt. of India which imposed an import duty, were able to compete. The third difficulty was caused by the entry of several competitors due to the low entry barriers as a result of low regulatory controls in India.

• Could you tell us the sectors your company caters to in the field of Medical Device Industry?

Our Company mainly manufactures blood bag systems and equipment used by modern blood centers.

• As a part of your involvement in medical device industry for many decades, could you please highlight the major changes which you have seen in the Indian Medical Device Industry?

From 1986, the Indian Medical Device industry has not grown as much as I would have expected it to. This is mainly due to the ineffective regulatory regime which enables all kinds of manufacturers to enter the market thereby creating difficulties for the quality conscious ones by reducing overall market size. A medical device company requires a minimum scale of operation to enable it to use the best technologies, and operate at economic scales of operation. That is why even today, most of the medical devices used in India are imported. Unless there is better regulation and enforcement of standards, the medical device industry in India will not be able to grow.

• Can you throw some light on the current status of the Indian Medical Device Industry with respect to share of different sub-sectors viz. medical equipments , medical disposables, diagnostics products etc.?

One problem common to all three product groups mentioned is that most products made in India are “me-too” products, with very little innovation. Many are made based on collaborations, or are copies of existing brands available in the market. There have been huge changes in the technology sector, and we should be incorporating these changes in our products. But, I have not seen too much evidence of innovation in product design or manufacturing technology among Indian firms.
 

• What are the policy and regulatory initiatives taken by the Government for strengthening of the medical device sector in India ? Do you see need for more initiatives?

After a long time, the Govt. of India have drafted a Medical Devices Regulation Act to substitute the Drugs Control Act for medical devices that has so far been in operation. I hope this new legislation will be adopted, as it is well drafted by an expert committee, and represents among the best such documents that I have come across in the world. If this is done, we will see the Indian medical devices sector take important steps forward to become a dominant force in the global market.