The marketing clearance of pharmaceutical products bearing brand names may soon become the exclusive domain of the Central Drugs Standard Control Organisation (CDSCO).

The central government's move in this direction has come after it was found that the domestic drug market is plagued with look-alike products with similar sounding brands. As per the proposed plan, the central authority will be asked to not only approve brand names, but also monitor each fresh application to avoid sanctioning of similar sounding brand names for other products. The vigilance would also help the agency track any change in the original approved combination of an established drug brand.

The government's move, along with the introduction of the Spurious Drugs Bill that talks about making look-alike drug manufacturing a non-bailable offence, is intended at putting an end to the practice of marketing drugs bearing similar brand names. While the restriction on look-alike drug brand approvals are to hurt the small scale drug manufacturing sector, the vigil over change in composition is to prove harmful to the interests of big pharma companies.

According to sources, the issue of controlling the system of brand approvals will be seriously dealt with in the new pharma policy that is being worked out by the Union Chemicals and Fertilisers Ministry. However, the Bill, which failed to make its presence in the just concluded session of the Parliament, gives more focus on look-alike brands than the practice of changing original composition of the approved brand. The Bill, which is being vetted by the Parliamentary Committee, has provisions to incorporate penal provisions under the Drugs and Cosmetics (Amendment) Bill 2005 to make such 'trade mark offences' a criminal act.

The SSI drug makers have always been arguing that the issue of spurious or substandard drugs should not be mixed up with trade mark offences. According to them, trade mark offences need to be handled by the Trade Mark Registry office while spurious drug manufacturing should be dealt with an iron hand.