The department of pharmaceuticals (DoP) of the Union Chemicals Ministry will soon call a joint meeting with the Union Ministry of Health to sort out the lingering Spurious Drugs Act issue about which the industry has been expressing concern over the misuse of the law against genuine manufacturers in the absence of a binding guidelines.
Union minister of state for chemicals Shrikant Jena has given an assurance to the industry to hold a joint meeting with health ministry to sort out the issue at the earliest. The assurance was given by the minister to an industry delegation which met the minister recently in Delhi to apprise him of the ground realities about the implementation the new Act, it is learnt.
Almost nine months after the Bill was passed in Parliament in November 2008, the Drugs and Cosmetics (Amendment) Bill, stipulating stringent penalties for manufacturing and marketing spurious drugs, was notified by the union health ministry recently along with guidelines. The notification was delayed due to the reservations expressed by the industry on the misuse of certain provisions in the Bill.
The industry was concerned that there are no provisions to safeguard the interests of the genuine drug manufacturers in Bill. Since there is no definition of substandard drug in the Bill, if any drug is found substandard the manufacturer will be charged for manufacturing and selling of adulterated or spurious drugs. Since this is a non-bailable offence under the new law, the manufacturer will be arrested and by the time he proves his innocence it will be months, or even years.
When the industry raised a banner of revolt against the Bill, the health ministry constituted a subcommittee under a senior official to go into the issue and the committee came out with some guidelines to take care of the concerns of the genuine drug manufacturers. Though the health ministry had assured the industry earlier that the guidelines will be binding, that is not the case now.
Though the industry has been voicing concern, ever since the health ministry notified the new Bill, to make the guidelines binding on the authorities to safeguard the genuine manufacturers, the health ministry officials so far lent deaf ears forcing the industry to approach the DoP to sort out the issue.
The industry feels cheated by the health ministry authorities as they feel that with the guidelines not binding on the authorities the new law will be complied more in its misuse by the drug officials, especially the drug inspectors who have been given sweeping powers under the law. There is an overwhelming fear in the industry that since there is no clear-cut definition on 'substandard drug' in the law to differentiate it with adulterated or spurious drugs, there will be misuse of the law which the industry has termed as more drastic than POTA and TADA.