The Department of Pharmaceuticals (DoP) will be shortly setting up three Good Laboratory Practices (GLP) compliant drug testing laboratories, one for chemical testing and another two for biological products testing, preferably in the pharma hubs through public private partnership (PPP) in an effort to ensure quality of drugs manufactured in India and to inspire innovation in the sector.
The estimated investment of the chemicals lab is of Rs 8 crore and the two biological labs is of Rs 3 crore each. The DoP will support the project with 50 per cent of the estimated investment and the projects are expected to take off in the current financial year. The project, which falls under the DoP's capacity building initiatives, will also be helpful for the drug companies in the backdrop of Health Ministry's decision to mandate GLP complied laboratories for all the licensed drug manufacturers.
The DoP, of late, has sought expression of interest from public funded institutes, public sector undertakings and private organizations working in the pharmaceutical sector.. The goal of the initiatives is to build up national facilities which can meet national as well as international regulatory requirements to test the quality and safety of the pharmaceuticals. The facilities are expected to come up in regions where there is concentration of pharma industry, such as Hyderabad or Ahmedabad.
The department is planning to continue similar projects in the rest of the 11th Five Year Plan and has allocated Rs 12 crore for chemical labs and Rs 9 crore for biological labs as for total requirements for three years beginning from 2009-10. After three years, assessment would be made for the outcome and would be continued accordingly, says DoP officials.
Recently, with the amendment of the Drugs and Cosmetics Act, the pharmaceutical companies has to conduct drug testing in GLP compliant testing laboratories as mandatory frp, September 2010. India, which has more than 10,000 manufacturing units according to the DoP estimations, has a huge lacuna in adequated GLP complied testing laboratories. Almost 300 quality control laboratories are there as inhouse facilities in companies in the organised sector, even as the rest of the majority relies on private testing laboratories which generally are non compliant with GLP norms.
Similarly, the biopharmaceutical sector in the country is still in an infant stage and there are very few players who can offer quality testing services to other companies as per international standards. Considering the expected growth of the sector in the near future, creation of a facility under PPP mode by way of giving soft loan to the existing or newly formed biological testing laboratories which is GLP Compliant will enhance the training facilities as well as the quality control of biopharmaceutical drugs and diagnostics, explains the DoP.
The funding for the chemical testing lab will be provided for purchase of the equipment and it will be released in two phases of 2 crore each. Funds up to Rs 1.5 crore to each biological laboratory be provided from the DoP even as the rest of the 50 per cent should be invested from the partner firm. The funding for biological lab will be provided for purchase of the equipment and it will be released in two phases of 75 lacks each.
The DoP will set up a committee with the approval of competent authority for evaluation of the proposals and for disbursement of funds.
However, since it is a national funded project, the partners has to maintain sample testing records and should test a fixed number of government funded or sponsored samples at cost or no profit basis per year.