FOPE organises seminar on GLP

Our News Bureau - New Delhi

The Federation of Pharma Entrepreneurs (FOPE) a Federation of Tax Free Pharma Units, organised a one day seminar on Good Laboratory Practices (GLP) on May 30, at PHD Chambers of Commerce & Industry, PHD House, Chandigarh with a view to update its member units on the importance of impending GLP norms, which have been notified and are to be implemented with effect from November 1, 2010. It was informed in the seminar that Ministry of Health has recently notified the Schedule L-1 of Rule 74,78 and 150 E under Drugs and Cosmetics Third Amendment Rule 2008 giving the pharmaceutical industry time till November 1, 2010 for compliance.

Dr Surinder Singh, Drugs Controller General of India (DCGI) was the Chief Guest on the occasion and the respective State Drug Control Authorities from the twin state of Himachal Pradesh and Uttrakhand also attended the seminar as guests of honour. Besides, the State Drug Authority of Punjab, Haryana, Union Territory of Chandigarh; Dr Y K Gupta, Chairman, GLP Committee of Govternment of India, A K Guha, Director, Central Drugs laboratory (CDL), Kolkata; and N R Munjal, President, Indian Drug Manufacturers Association (IDMA) were also present. Various panelists from the industry and regulatory authorities participated in open discussions on the subject and also attended the question answer open house session. Around 150 pharma units from the two states and their quality control executive participated in the seminar.

Initially deviating from the main topic of discussion, B R Sikri, Co-Chairman, FOPE emphasised on role of FOPE in the industry. He informed the gathering that FOPE defended the interests of respective member mainly at the central level and respective state level associations take care of the interest and needs of local companies. FOPE has now acquired the name and fame not only at the State level but also at Central level. He said that pharma industry should contribute in the state of Himachal Pradesh and Uttarakhand in generating employment, revenue by setting ancillary units, development of logistics, printing and packaging units etc.

B K Gupta, Chairman, FOPE, elaborated on the various issues affecting the pharma industry with specific reference to the industry located in tax free zone, eg issues related to rate of excise-duty, fixed dose combinations, the Spurious Drug Act, National Pharmaceutical Pricing Authority (NPPA) issues etc. He also gave the future road map to the gathering and informed that the Federation was planning to appoint various sub-committees in different fields like marketing, bulk drugs, taxation, NPPA related issued, FDA publications, regulatory and technical quality management, membership and constitution etc, so that maximum number of members are involved in the activities of the Federation. FOPE is also planning to bring in its fold the units located in the States of other hilly areas like Jammu and Kashmir, Sikkim etc. He informed that the federation was also planning to institute various awards for the best companies amongst its members in each discipline of the pharma industry.

Speaking on the occasion, the DCGI congratulated the manufacturers for putting up pharma units in tax free zones in a short time. He also complemented FOPE for taking the lead in organising a seminar on GLP well ahead of its implementation.

The seminar emphasised on the implementation of GLP and the responsibility of companies to comply with them while carrying out quality analysis. GLP stresses on the maintenance of documented quality systems as per the quality manual laid down by the manufacturing unit, and on the technical audit of the quality control laboratory for GLP compliance by an expert/experts appointed by the top management other than the person in charge of the laboratory.

Deliberating on NPPA issues relating to pricing of scheduled drugs, the seminar explained FOPE members the importance and consequences of NPPA rules. There was also an open house session on the procedures of registration of new/existing molecules under the chairmanship of the DCGI.

Towards the end, Navneet Marwaha, Drugs Controller, Himachal Pradesh, extended vote of thanks on behalf of Himachal Pradesh Government, and Vinod Kalani, General Secretary, FOPE thanked all the dignitaries, delegates from the pharma industry and the officers of Central and State Governments.