Stabicon Life Sciences, a contract research provider, has received the WHO (Geneva) certification to conduct analytical testing. The company which is already approved by NABL, Health Canada and is registered with the US FDA sees that it could further augment its presence in the contract research in the international regulated markets.

The company is amongst the three independent labs in South Asia to be approved by WHO (Geneva) under Prequalification Medicine Program – Procedure for Assessing the Acceptability, in Principle of QC Laboratory for use by UN agencies.

“We have invested around Rs.12 crore in the facility to comply with international standards in terms of equipment, processes and systems. A lot of emphasis is given to train our team to handle stringent global regulatory requirements and particularly data integrity. We have a qualified team in place headed led Vijay Ranka, director operations to achieve this objective,” Suresh Khanna, chairman, Stabicon told Pharmabiz.

“Currently, we are engaged in broadening our activity from a mere analytical and stability service provider to a more strategic, integrated project-driven resource major. We are extending our services to lab scale formulation development for solids, semi solids and liquid orals dosage form. The objective is to provide these services to the regulated markets like UK, Europe and South Africa at competitive cost and faster turnaround time”, noted Khanna.

India’s contract research is valued at $1.5 billion and is registering a compounded annual growth rate of 12 per cent annually. The leading players in the space are GVK Biosciences, Syngene, a subsidiary of Biocon, Synapse Labs in Pune, TCG Life Sciences , Vimta Labs, Rubicon, STAR part of Strides Arcolab, Neuland Labs and Semler.

However, the industry’s present challenge is to get the pharma products into India within 30 days from its date of manufacture for stability studies as per the regulatory requirements. Now this unfortunately is a big hurdle today due to our present system of getting no objection certificate (NOC) from the Drugs Controller General of India (DCGI) office New Delhi, he said.

“We have already taken up this issue with the concerned authority for issue of import NOCs from CDSCO’s Zonal and Sub Zonal offices . Once these processes are streamlined and procedures are put in place, we expect to increase our business substantially wherein analytical and stability samples can be brought in expeditiously to India,” noted the Stabicon chairman.