The Drugs Controller General of India (DCGI) is planning to set up its subzonal office in Chandigarh. The office is likely to be operational by December this year.
The move is expected to benefit over 450 units located in the tax-free zone of Himachal Pradesh, besides Punjab, Jammu & Kashmir and some parts of Haryana, as they can get clearances and approval locally. At present, these units have to go to Ghaziabad to obtain approval.
Surinder Singh, Drugs Controller General of India, said, “Recently, we had set up a subzonal office in Banglore and in order to facilitate the northern region-based companies we are planning to set up subzonal office in Chandigarh.” There are four zonal offices currently in India at Mumbai, Chennai, Kolkata and Ghaziabad and two subzones at Hyderabad and Ahmedabad, The subzones will be upgraded as full-fledged zones soon, he added.
The subzone in Chandigarh will look after facilitation of inspections, issuing of licences, approvals and eventually manage clinical trial audits.
The total turnover of the 450 units located in Himachal Pradesh alone is to the tune of Rs 3,500 crore.
The DCGI plans to organise a series of seminars on good laboratory practices, which will come into effect from November 1, 2010. These seminars would emphasise on implementation and responsibility of the company to comply with GLP while carrying out analysis.
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He said the department would recruit around 250 employees across India in different departments.
Meanwhile, the Federation of Pharma Entrepreneurs, which organised a seminar on GLP in Chandigarh, is planning to appoint various sub-committees in fields like marketing, bulk drugs, taxation, FDA publications, regulatory and technical quality management, membership and constitution. The federation is also planning to bring into its fold the units located in the states of other hilly areas like Jammu & Kashmir and Sikkim.