National Institute of Biologicals (NIB) has issued a circular for the constitution of two Core Groups for conducting a scientific study on the extent of problems of spurious drugs and drugs not of standard quality. For the core group to plan and devise the survey plan, NIB has identified Terms of Reference (TOR) to develop statistical drug sampling and a methodology in consultation with Indian Statistical Institute, New Delhi.
The meeting is to be convened on November 15, 2013 to discuss the design and modalities to be adopted for such a study at the national level and to assess the extent of the problem of spurious drugs and NSQ stated the circular issued by Dr Surinder Singh, director, NIB and nodal officer of the project who was the former Drugs Controller General of India (DCGI).
The circular issued via No. N1-26/2013 NIB Drugs, stated that first core committee for planning and designing the survey plan and its implementation would be chaired by Dr B R Jagashetty, former drugs controller, government of Karnataka.
The second Core Committee would identify the National Accreditation Board of Laboratories (NABL) led by Dr N Murugesan, director, Central Drug Testing Laboratory, Chennai coming under the Central Drugs Standard Control Organisation (CDSCO).
The action plan for the Core Committee 1 would also be to identify the fast moving drugs from the National List of Essential Medicines (NLEM) and market for drawing of the samples under the survey. It would oversee implementation of the survey and coordinate its various activities.
The terms of reference for Core Committee 2 are identification of NABL approved and government and private Dugs Testing Labs. It will negotiate with NABL approved private Dugs Testing Labs on the fee to assess the samples in accordance with the Schedule B of the Drugs & Cosmetics (D&C) Act and Rules.
Further the Core Committee 2 would also propose testing fee justification for the analytical assays for the drug samples for which testing fee is not provided in the Schedule B of the D&C Act and Rules.
The Committee would also have the responsibility of projecting the budgetary allocation for drawing of the drug samples, transportation, storage and shipping to the Drug Testing Labs, testing fees and other miscellaneous expenses related to the same.
While the other members of the Core Committee 1 are Dr S K Gupta, Prof. Emeritus and head, clinical research, DIPSAR, New Delhi, Dr Urmila Thatte, head, Clinical Pharmacology department, KEM Hospitals, Mumbai and president Indian Society for Clinical Research, Bijon Mishra, founder, Partnership for Safe Medicines, India, MC Deka, drugs controller, government of Assam, DK Shringi, former drugs controller , government of Rajasthan, Dr N Murugesan director, CDTL, Chennai, Dr S Manivannan, deputy drugs controller (India), CDSCO, sub zone, Bengaluru, Dr Madhur Gupta, technical officer, WHO-India, nominee director, Indian Statistical Institute, New Delhi, Dr Robin Kumar, senior scientific officer, IPC and Akanksha Bisht, scientific assistant, IPC is member –secretary.
There would be a few members from Core Committee 1 who would work in a similar capacity along with Dr R A Singh, RDTL, Chandigarh, Dr K Bangarurajan, DDC(I), CDSCO, north India, Dr Sudha Swami, chief scientific officer, DTL, Bengaluru, Chandan Kuamr, finance officer, IPC, Ghaziabad, Dr Bikas Medhi, additional professor pharmacology, PGI, Chandigarh, Lotika Khajuria, DDC, Jammu, Navneet Marwah, DC, Solan HP.