IMPERFECT POLICY

After a gap of 18 years a new pharmaceutical pricing policy is going to be notified by the Central government once that is cleared by the Union Cabinet. The Group of Ministers (GoM) approved the policy draft on last Thursday to bring formulations of 348 bulk drugs under price control as against 74 drugs and their formulations in the 1994 drug policy.

A major deviation in the new policy is the adoption of market based pricing for fixing formulation prices instead of cost plus formula followed currently. Under the new system, the prices of drug products will be fixed on the basis of the average price of all brands in a therapeutic segment that has more than one per cent market share. Another major change in the policy draft is the exemption of bulk drugs from the ambit of price control. By expanding the list of price controlled formulations in the new policy.

GoM said that the span of control in the pharmaceutical industry would be 30 per cent as against 18 per cent currently. As per the 1994 drug policy, the companies were also allowed to raise prices up to 10 per cent every year in case of all drugs other than the 74. And as a matter of right, the companies have been jacking up the formulation prices of more than 500 drugs which are outside price control even when their costs remained static or dropped.

The new pharmaceutical policy leaves as much as 70 per cent of the drug products marketed in the country outside any kind of price control. Definitely this is a policy intended to benefit the pharmaceutical industry and not in the interest of the patient community. Organization of Pharmaceutical Producers of India representing foreign drug companies and Indian Pharmaceutical Alliance, a body of top dozen Indian companies are not happy with new policy as they consider the profitability of their member companies may be hit.


By taking average of prices of all brands in a therapeutic group for price fixation can bring down prices of some products of MNCs and top Indian companies. Because, product prices of these companies are very high whereas prices of many medium and small scale companies are much lower.

Untested - Drug's

Central Drugs Standard Control Organisation last week came out with a stand that it will not review or recall the 33 controversial drugs found to have been approved for marketing in the country during 2008-10 without clinical trials by the Parliamentary Standing Committee on health & family welfare. The conclusion of the Parliamentary Standing Committee was that  a collusive nexus existed between medical experts, pharmaceutical companies and the CDSCO officials while approving drugs for marketing in the country.

The report of the panel also pointed out the unethical deals between the pharmaceutical companies and the regulatory officials in getting approved the unsafe drugs in India. The CDSCO is of the view now that approvals granted by the competent authority were 'in order' and there was no need to re-examine the approvals or recall any  drug from the market on grounds of errors in approval process. Therefore, there will be no action with regard to these 33 drugs unless some specific instruction come from the Union Health Ministry.
 
An expert committee has been constituted to suggest measures to improve the functioning of the office of CDSCO and DCGI soon after Standing Committee’s report came out last month. The three-member committee is headed by V M Katoch, director general of the Indian Council of Medical Research. This committee is also expected to look into specific cases against medical experts and suggest actions to be taken by the Medical Council of India.

The health ministry has  to remember that there was tremendous  pressure from the public interest groups and independent medical experts for taking immediate action to suspend marketing of these drugs circulating  in the country. The fact is that these drugs, without assessing their safety and efficacy, are already there in the market and are being prescribed by the physicians. It is quite difficult to estimate how many people might have already injured and suffering due to intake of such untested drugs. No drug control administration should ever dare to allow the pharma companies to market any medicine without proven efficacy and safety.