Sipra Labs foraying into clinical trials segment

City-based Sipra Labs Private Limited is gearing up to become a fully integrated contract research organisation.

It is foraying into clinical trials segment and also plans to offer dossier preparation services. The company is at present in talks with a few hospitals in Hyderabad, Bangalore and Mumbai to commence clinical trials.

The Rs 10-crore company is also setting up a Rs 15-crore facility as part of the first phase of its expansion plans. The new facility is likely to come up at Miapur on the city outskirts by the year-end. It has also embarked on a recruitment drive to double its R&D team strength to 200 in the next two years, he said.

The first phase of expansion is to be completed in 18 months and under the second phase, the company is planning to venture into basic research, formulations and new drug delivery systems.

"Our foray into clinical trials as well as dossier preparation services would enable Sipra to facilitate the passage of new drugs through the regulatory approval process to market entry," V Satyanarayana, managing director of Sipra Labs, told Business Standard.

Explaining the clinical trials' foray, Satyanarayana explained that it differs from bio-equivalence studies in that phase-3 clinical trials involve tests of drugs on a few thousand patients whereas bio-equivalence studies are conducted on healthy patients numbering below 100.

Bio-equivalence studies are carried out to prove ethicacy and bio-equivalence of the drugs while clinical drugs are conducted to understand the efficacy of the drugs, he said.

"Indian contact research organisations (CROs) are in a better position than the foreign players since they can easily source patients and conduct trials at competitive rates. The CRO segment is in for a boom. However, the government needs to take care in enforcing the guidelines strictly for CROs to check any fly-by-night operators which could earn the country a bad name and do immense harm," Satyanarayana observed.

Though Indian pharma companies like Dr Reddy's, Lupin, Panacea Biotec, Ranbaxy, Sun Pharmaceuticals and Wockhardt have either set up their own CRO divisions or are in the process of setting up such divisions, the market is big enough and has room for all the players, he said.

On the dossier preparation services, he said that it involved common technical document compilation and other dossier types and management of critical clinical documentation including clinical study reports, investigators brochures and standard operating procedures.

Sipra has expertise to cater to the norms set by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Sipra Labs can customise the ICH procedures to requirements of regulators in various countries.

The 10-year-old Sipra Labs at present provides specialised services to the pharmaceutical and biotechnology players for bio-availability, bio-equivalence, stability and method development studies on drugs.

Besides these, it also renders research and development of drugs, pharmaceuticals and drug intermediates. It has around 750 clients in the pharma sector and conducted around 300 bio-equivalence studies in the last two years.