Even as the Drugs and Cosmetics (Amendment) Bill, 2005, which was recently passed by Parliament, is waiting for the President's nod to become an Act, the small scale industry has urged the union health ministry to take steps such as strict adherence of storage conditions specified on the labels of the drugs and also adherence of jurisdiction and other stipulations on invoices of manufacturers to protect the genuine manufacturers.
Apprehensive of several provisions including the provisions on spurious drugs in the new law, the SME Pharma Industries Confederation (SPIC) in a letter to the health ministry asked to initiate steps to ensure that storage conditions on labels of the drugs are followed strictly by all concerned. The SPIC's plea stems from the fact that as per the new law, even the substandard drugs are considered spurious drugs and the manufacturer will be arrested without bail. And one of the major reasons for drugs turning substandard is storage conditions, industry sources say.
More than half the medicines carry a mandatory storage direction - 'Store in a cool dark place and/or protect from light'. But not a single transporter has air-conditioned trucks or godowns where goods may be lying for months. Subsequently, even chemist shops lack air-conditioning. Those who have it do not get supply of electricity. One can well imagine the fate of medicines carrying these directions when they are kept in 45 Celsius for prolonged period. Manufacture of spurious drugs is a clandestine activity which involves using labels of licensed units. Once the offence is made cognizable, the clandestine manufacturer will be nowhere in the picture while the honest manufacturer will not get bail for no fault of his, SPIC said.
Other measures demanded by the SPIC included jurisdiction and other stipulations on Invoices of manufacturers should be adhered to, guidelines of 1993 DCC need mandatory implementation by SLAs and vigilance needs to be mounted to detect production of spurious drugs and ensure unscrupulous elements are located and effectively nailed under the new law.
The Drugs and Cosmetics (Amendment) Bill, 2005, stipulates stricter penalties like life imprisonment and non-bailable arrest for manufacturing and selling spurious drugs. But what is worrying the drug manufacturers is the lack of any interpretation on substandard drugs. In the absence of this, even the substandard drugs could be interpreted as spurious drugs.