READ ONCE | POWER CORRUPTS : ABSOLUTE POWER CORRUPTS ABSOLUTELY
There is yet another land mark judgment reported in 2010(1) Drugs Cases 277, Allahabad, DB, (Brahmaji Vs State of U.P. & Ors). High Court issued the following directions:
(i) that the Central Government and the State Government will both give a clear indication as to how they plan to take effective action for controlling menace of spurious drugs;
(ii) the State Government to ensure within two months all the requisite manpower and required infrastructure, i.e. creating adequate number of laboratories etc;
(iii) both the Central Government and State Government to inform this Court as to what strategy they propose to adopt so that focused raids are conducted and samples taken so that effective measures can be made for identifying the manufacturers or dealers in spurious drugs;
(iv) the State Government to inform the Court about the time frame in which the computerization system of which the plan has been submitted by the NIC will be operational.
Note: U.P. has 71 districts, 53 Drugs inspectors, 400 manufacturing units, 180 blood banks, 50000 retail and 40000 wholesale outlets.
The provisions of Drugs and Cosmetics Act 1940 and Rules 1945 made there under are nicely designed, except the latest amendment of 2009, but these are being misinterpreted, misguided, misused, wrongly targeted, abuse of powers vested in so-called Experts in department of Drug Control whether Central or State. It is very convenient to demonstrate with evidence that these officials are involved in activities against the provisions of the ‘Act’ and ‘Rules’. They are least interested to safe guard public health even on written complaints with evidence, they prefer to negotiate with the erring person(s) and keep shut.
Such officials in majority cases are badly infected with C.Coli (Corrupto Coli) and could be for the time being be treated with veterinary dose of M.cillin Tabs. 10000 mg S.O.S.
Therefore it is rightly said ‘POWER CORRUPTS AND ABSOLUTE POWER CORRUPTS ABSOLUTELY.
The author dare say that the pharma SMEs in majority cases has been the victim of GANG RAPE by the (un)qualified, (un)trained and (un)skilled regulatory and Lab. Officials, Political leadership, Top bureaucrats and MNCs/LSI in the country. Exceptions are always there.
Look how the Pharma SMEs became victim of GANG RAPE
1. MNCs and Large Scale Industry was given FREE hand to market Generic Drugs in the country- who gave tough competition to SSI
2. National / State procurement Agencies included eligibility criteria in their tenders for purchase of medicines like
(a) Annual Turn Over of ranging from 5 to 50 crs.
(b) Possession of WHO/DGQA certificate for product(s) being offered;
(c) Minimum three years experience of manufacturing and marketing of product(s) being quoted. and
(d) Earnest Money Deposit in cash to tune of lakhs of rupees.
3. Creation of TAX FREE ZONES
4. Notification of Revised Schedule M
5. Excise Duty on MRP
6. Criminal Prosecutions on false, baseless grounds and without any investigation, under the ‘Act’ and ‘Rules’ at other than manufacturing State.
7. Notification of Drugs and Cosmetics (Amendment) Act 2008 (Commonly known as Spurious Drugs Act)
8. Notification of Good Laboratory Practices.
Thus the number of Industry of modern medicines which was 20000+ in the year 2000 is reduced to 10000 in the year 2007 as per Government data. BUT actually data as on date is not more than 5000 actually functioning. Where 80% business share goes to 20% MNCs/LSI and 20% business to 80% SMEs.
The only suggestion that the Government should take over willing SMEs in the country, paying them market value of their industrial assets and run those industries as government enterprises. If this is implemented all the problems shall be solved in one stroke.
Let us have faith that right makes might, and in that faith, let us, to the end, dare to do our duty as we understand it……Abraham Lincoln
If you have ten thousand regulations, you destroy all respect for the law.
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