Suraksha Pharma, the Hyderabad-based manufacturer of psychiatric and neurology drugs, is all set to commence its research and analytical laboratory at Roorkee in Uttaranchal. The company is waiting for approval from Drug Controller General of India (DCGI) to launch its commercial operations. The state authority has already examined the facility and given the green signal.
Talking to Pharmabiz, M Nageswara Rao Gupta, CEO of Suraksha Pharma, said, "The facility will cater to the increasing demand for clinical and analytical studies for various molecules. We will conduct various studies from bio-equivalent studies to full-fledged contract research."
To be called as Roorkee Research and Analytical Laboratory Private Limited, the facility has been set up on 20,000 sft area. Total investment, including erecting the physical structure and installation of equipments, was between Rs two to three crore. The equipment is imported from Japan and South Korea, Rao said.
"Currently, the lab is good laboratory practice (GLP) compliant and Schedule-M certified. We will go for WHO- cGMP (current Good Manufacturing Practices) certification by the end of this year, so as to scale up the business activity", he added.
With the start of operations, the company is expecting around 1,500 clinical analysis studies in a month. The business would be around Rs 10 lakh a month which puts the annual dealing at around Rs one crore, he said. The company has hired around 20 scientists for the facility. Towards the year end the total head count would go up by 50 personnel. The company at present has staff strength of over 100 people.
When asked about the demand for such labs, Rao said, "Presently, the companies that have shifted from other places are facing certain issues one of which is research and analysis. They conduct the studies at Delhi, Hyderabad, Bangalore or Mumbai and other areas. The timeframe is a crucial area wherein commercial labs like Roorkee Research are of much help to the companies that desire to capitalise on time duration. Our target is to minimize the time duration."
The company is planning to conducts phase II and III clinical trials as well as bio-equivalent and bio-analytical studies but not phase I trials in near future, he said.
To a query as to whether the company would go for contract manufacturing in near future, he said, "The company is very much positive about this and we have established another venture Suraksha Pharma Private Limited in 2006 which is a third party CRM (Contract Research Manufacturing) organisation with an investment of Rs 2.5-3 crore."
The Roorkee arm is tablet and capsules manufacturing unit with installed capacity of nearly 50 crore tabs and 25 crore caps in a year. Both the lab and manufacturing facility will cater to the company's future plans with regard to domestic as well as export business in future. The company proposes to invest up to Rs. 10 crore in coming years.
The company is growing at 60 per cent rate on an average every year. During 2006-07 the company recorded Rs 1.5 crore worth of business. In coming couple of financial years it is looking at Rs 5 crore target. The major areas of operation in the country are Andhra Pradesh, Kerala, Orissa, West Bengal and Maharashtra, he added.
The company is into manufacturing of anti bacterials, anti pyretics, haematinics, anti diarrhoea, anti ulcerants, softgelatins, and neuron psychiatry. The company also plans to tap parenteral market in future.