SHIELDING THE PROGRAM FROM THE OMNIPRESENT MENACE OF SUBSTANDARD AND SPURIOUS DRUGS IN INDIA:


·        About 20% of all medicines could be fake or substandard in India reported an article in The Week, May 18, 2003.

·        The India Pharma Alliance (IPA) claims an annual damage of Rs. 4,000 crore to pharmaceutical industry due to spurious drugs.

·        For monitoring India’s mammoth pharmaceutical industry, drug-testing facilities are pitiably deficient, almost non-existent.

·        Confederation of Indian Industry (CII) submitted before government’s own expert Mashelkar committee conducting ‘A comprehensive Examination of Drug Regulatory Issues’ that: ‘Government drug supply: majority fail quality test.’(Page 75 of the report).

After all, drug procurement by govt. agencies is a massive and lucrative ongoing exercise and everyone down the assembly line – politicians, bureaucrats, DGs, CMOs, SMOs, program officers, clerks and accountants are in a position and some ceaselessly try to extract their pound of flesh.

Given a murky drug-quality background and an omnipresent menace of spurious and substandard drugs in India, it hardly inspires one’s confidence to notice that, rather than only international companies of repute, any Tom, Dick and Harry seems able to bag orders to manufacture and supply drugs for DOTS pipeline – e.g. little known firms like the following:

·        Micron Pharmaceuticals, 2117, A-2, Phase III, GIDC, VAPI 396195.

·        Pure Pharma Ltd. 41, 42 and 44, Industrial Estate, Polo ground, Indore 452015.

·        Vysali Pharmaceuticals Pvt. Ltd. IX / 639 EDATHALA, Cochin – 683561 etc.

(Note: since no research has been done on these specific firms or their credibility or quality of the products mentioned above, these observations are in no way meant to imply that the drugs were substandard).

Even if we presume for a moment that everything else under this program works just perfect, a sloppy control over drug-quality can single-handedly ruin everything across the board – just like that one drop of urine in a bowl of soup.

In 2003, the most sensitive duty of monitoring the drug quality was out-sourced to a private Hyderabad firm. Will the move pay dividends? Or has the law of averages already caught up with strips of RNTCP? Only time will tell.