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Dangerous doses

Domestic Pharmaceutical companies agreed last week to withdraw 120 combination drugs from the market, in response to state drug regulators’ missive.

india Updated: Nov 04, 2007 21:13 IST

Domestic Pharmaceutical companies agreed last week to withdraw 120 combination drugs (270 brands worth about Rs 1,000 crore) from the market, in response to state drug regulators’ missive. On the face of it, this is a welcome step. The state regulators got into action after the Drugs Controller General of India (DGCI) issued a directive to immediately withdraw from the market, and suspend production of, 294 combination drugs (1,100 brands, worth over Rs 3,500 crore), manufacturing licences for which had been granted without the mandatory approvals to large and medium pharmacos. Industry wants the government to go easy on the remaining 174 combinations (830 brands worth Rs 2,500 crore), the argument being the significant loss of revenue and the ‘shortage’ of drugs that such a withdrawal of medicines might trigger. For the paranoid, the voluntary recall can be seen as a bit of a sop to the drugs regulator.

If it weren’t bad enough that doctors have been prescribing combination drugs that have not passed the qualifying tests, the parameters of industry’s negotiations with the State — revenue and ‘popularity’ — make the matter all the more dubious.

All along, it’s been the issue of the easy availability of spurious medicines that got the alarm bells ringing. Yet, it will serve the nation well to know what medicines the established names are flooding the market with. Considering that the top pharmas’ combo medicines are tweaked compositions of licensed drugs, fears of inefficacy may be limited. But it is sheer malpractice that the industry’s biggest names choose to bypass regulations and worse, are granted manufacturing licences by the authorities. After all, the point of testing is to ensure the result and identify side-effects. The industry argues that it takes over 18 months for approvals and it is estimated that close to 2,300 applications for combination brands are pending with the DGCI.

Be that as it may, it is imperative that the industry and the State keep patient welfare as the core issue when reaching a consensus on granting licences and manufacturing drugs. A little paranoia here can go a long way in ensuring that the doctor knows, for a fact, that his potion is not poison.