Government decides to free trade from Rule 67 obligation

Jayashree Padmini - New Delhi

Consequent to pressure by drug traders, the government has prepared a draft document to amend Rule 67 of the Narcotics Drugs and Psychotropic Substances Act, that will liberalise the entire system. Senior officials in the Narcotics Control Bureau told Express Pharma Pulse that the proposed amendment envisages to free the whole distributor chain from the additional documentation by way of Form 6.

This means, starting from manufacturer to wholesaler, stockists, dealers, and retailers will not be required to maintain Form 6.

Rather, the government would be happy with the invoices that are kept by the players in the distributor chain. However, the invoice needed to contain information such as name of consignor/consignee, license number, description of drugs, batch number and quantity and transportation details.

Officials pointed out that if the manufacturer/trade is finding the Form 6 a documentation burden, we will provide them an alternative and accept their conventional documents.

‘‘However, what is ironic is that the Form 6 seeks such information that is routinely maintained by the trade/manufacturer in their invoices,’’ quipped the official. The officials expect that with the liberalisation of the regime the massive problems caused by disappearance of essential medicines from retailer shelves will be sorted out.

In a couple of days, the government is expected to notify the amendment to the Rule 67 of the Narcotic Drugs and Psychotropic Substances Act. The draft notification prepared by the finance ministry that will see the distribution chain exempted from the formalities of the mandatory consignment note, is circulated to the manufacturers/trade, said official sources. This is to take the stake holders in confidence and to sort out the problem, said the official. The document will be finalised taking the feedback from all stakeholders and will be notified shortly, said the official.

The official said that according to the draft, Form 6 will not be applicable to the sale of psychotropic substances effected by way of wholesale dealing to hospitals, dispensaries, medical education institutions, medical research institutions or any other persons duly licensed under Drugs and Cosmetic Rules for retail sale, provided the invoice in accordance with the rule 6 of the Drugs and Cosmetics Rules 1945 is in place.