The pharmaceutical industry in the country is upset over Drug Controller General of India (DCGI)'s directive to the state drug authorities in which the DCGI is reported to have asked state authorities to implement the recent changes in law to punish companies making adulterated drugs as well as those drugs that copy an established brand but may not necessarily be harmful to consumers (spurious drugs).
The government had recently amended the Drugs and Cosmetics Act to enhance the punishment for manufacturing and marketing of spurious drugs. The government has also made this offence cognizable and non-bailable. Union health ministry had recently notified the Bill with the attachment of some safeguard guidelines.
The industry fears that as per the instructions of the DCGI, action will be taken by the state drug authorities even when there is dispute over brand name, design, colour scheme, trade address etc. These are Intellectual Property issues totally distinct from public health issues.
Even the WHO was forced to drop the intellectual property rights from the health issues (in the garb of new definition of counterfeit) since they are private rights which each individual party has to protect themselves. It is rather unfortunate that this conspiracy has now been hatched in India, industry sources regretted.
The industry will soon approach the government to delink the two issues of quality of drugs and the intellectual property rights. The industry will also start a campaign to get the definition of 'spurious drug' revised to exclude intellectual property disputes and substandard drugs. It will also ask the government to press for making the guidelines attached to the newly amended lay mandatory and binding by notification and also to get a new definition of 'sub standard' drugs so that the new provisions are not applicable to it.