Bhavana Shah is President of the Indian Pharmaceutical Machinery Manufacturers Association (IPPMA), which has membership of over 150 pharma machinery manufacturing units in India. In an interview with Pharmabiz, she talks about the potential challenges faced by the domestic manufacturers from overseas companies, stress given by Indian manufacturers on areas like R&D and investment and on the bright prospects for the Indian manufacturers in various global markets. Excerpts:

As the President of the IPPMA what is your assessment of this industry?

We are growing 15-20% annually and there are more than 700 units today, that are supplying machines to the pharmaceutical industry in India and worldwide. I therefore see a bright future for this industry.

In terms of quality, how do you rate pharmaceutical machinery produced by India's domestic industry in comparison with those produced by the US and European companies?

I must admit that the quality of our machines is not at par with those produced by American and European companies. The machines produced by our foreign counterparts are however, five times more expensive than our machines, for the same products and in the same capacity. We need to invest in development and research to reach to their level, but because our products are cheaper, people still look to the Indian market for those products.

Implementation of GMP under Schedule M is going to be mandatory for all drug units in the country from July 1. How this regulation is going to help the pharma machinery manufacturing industry?

The implementation of GMP under schedule M has already been very helpful. Since the last one year, the Government has been extending the deadline for implementation. Many pharmaceutical companies have already started their preparation based on the Schedule M norms, and as a result, our industry has a lot of orders. In fact, since the last 18-24 months, each and every machine manufacturer has a good production load.

Do you think the small players will be able to survive in this newera, as they will have to deliver high quality products at much higher costs?

For the pharmaceutical machinery industry, this is a very critical stage. Those days are gone when you could just duplicate and sell European machines. Every small player has to now attempt to increase their production capacity, and simultaneously work towards upgrading their technical know-how to reach international standards. I feel that for this reason, in-house R&D departments are a must. Many of our members are continuously working on this - It is a difficult task to reach international standards, but at the same time, it is not an impossible one.

Contract manufacturing and R&D are going to be two potential growth areas in this industry in the years to come. Is the domestic machinery industry capable of meeting the requirements of these segments?

Yes. We are capable of meeting those requirements. Most pharmaceutical companies export their products to regulatory markets today. They want machines that are approved by either US-FDA or UK-MCA. We take the issue of upgradation, documentation and validation very seriously. IPMMA actively organizes seminars in this area for the very same reasons.

Import of pharmaceutical machinery and equipments into India from Germany, Sweden, Italy and Japan at high prices is increasing of late. Do you think this is going to be threat to large domestic units? If so what is your strategy to face this situation?

There has been a growing trend of importing machines from those countries and, it is certainly a threat. As an industry, we are working towards changing the quality of our machines to match their quality. I think this upgradation, documentation and validation procedures adopted by us can help to counter this trend.

You also have a threat of cheaper machinery import from countries like China, Korea and Taiwan. How you are going to tackle this challenge?

Every segment has its own positive and negative sides. Imported machinery from countries such as China, Korea and Taiwan is cheaper but pharmaceutical companies often look for better quality, after-sales services and US FDA/ UK MCA approvals. When compared with American and European manufacturers, our machines are cheaper and with our constant endeavours towards reaching international standards, in my opinion, we can cope with that challenge.

How do you find the availability and prices of these raw materials in the country?

The ordinary grade Stainless Steel used in Pharma Industry SS 304 & SS 316 (Low Carbon) is available through stockists, traders whereas producers like SAIL and Jindal give direct supply, if order quantity is more and deliveries like 2 to 3 months.

The question of original Mill Certificate and tractability still remain a problem with Stockiests/Traders. This requires third party stamping and testing in a reputed Laboratory. The requirement of SS material for exports to European countries and USA required material conforming to DIN STD 3.1B which sometimes very difficult to get from reputed manufacturers like Jindal & Mukund Steel.

Even as on today, SS pipes suitable for Pharma applications such as ERW or Seamless, we are still dependent on imports from Sandvik or other suppliers. Our country is still to establish such quality plants. India is still dependent on imports for all specialty SS material required for precision application and prices are high because of ruling Nickle & Moly prices internationally.