Plans are on card for the government to institute a method of widely publicizing GMP certification as a guarantor of quality of the certified drug, says the draft of National Pharmaceuticals Policy-2006.
In addition a quality mark like the ISI or Agmark approvals would be evolved through industry involvement - BIS would be involved with the grant of these quality marks.These marks would be awarded only on submission of bioequivalence and bioavailability studies to the DCGI .
A dedicated fund would also be created for providing interest subsidy (5 per cent) on borrowings to small scale/medium pharma units going in for Schedule M implementation for GMP for Drugs and Cosmetics Rules.
This assistance would be in addition to any other financial assistance that may be available to the SSI pharma units from central or state governments.
While SIDBI would be the nodal agency for this scheme, other banks / financial institutions would also be involved in this work. Promotional activity to motivate industry to adopt schedule M would also be undertaken from this fund with the active involvement of Ministry of Health and Family Welfare and the states.
The prevailing system of drug certification is completely opaque as far as the therapeutic quality and effectiveness of different brands are concerned, certainly to the patient and also possibly for the doctors. The Indian Pharmacopeia (IP) certification or its equivalent in other countries, attests the quality of the API in most cases, and not to the quality of formulation, which is what the patient actually purchases.
Different formulations of the same API are perceived to have different levels of effectiveness due to different bioequivalence of the APIs, differences in the excipients or the drug delivery technology. Lack of adequate information and awareness may lead to 'adverse selection' behaviour, whereby a higher price is associated with better 'quality'.
The revised Schedule M of the Drugs and Cosmetics Act, 1940 related to Good Manufacturing Practices (GMP) has come into effect from July 1, 2005. This in the long-run would strengthen the pharma industry as a producer of quality medicines.
India is today recognized as one of the leading global players in the manufacture of pharmaceuticals holding 4th position in terms of volume and 13th in terms of value of production. It is also recognized that the cost of drugs produced in India is amongst the lowest in the world. It is estimated that by the year 2010 industry has the potential to achieve Rs 1,00,000 crore in formulations with bulk drug production going up from Rs 8000 crore to Rs 25,000 crore.
- Y V Phani Raj, Hyderabad