The Drug Controller General of India's (DCGI's) move to bring an amendment to Drugs & Cosmetics Rules so as to bring narcotic drugs and psychotropic substances under the purview of Central Licensing Approval Authority (CLAA) is being opposed by the drug manufacturers. The new rule cannot bring any control over these drugs in the distribution channel, industry sources said.

The government had issued a set draft rules in mid June to bring in the narcotic drugs and psychotropic substances under the purview of Central Licensing Approval Authority (CLAA) and has sought the manufacturers of drugs in this category to file additional information in a new form.

However, the industry sources said that the rules would not curtail misuse of narcotic and psychotropic drugs, as it lacks proper definition of narcotic substances. There are thousands of molecules in the market which have similar properties like that of NDPS. The rule also lacks provisions to control the distribution channels, where most of these drugs are likely to be misused. The Indian Drug Manufacturers Association (IDMA) is preparing a detailed memorandum on the issue and will soon submit it to the DCGI, it is learnt.

The state drug regulatory authorities, as of now, do not have expertise in checking the narcotic drugs and psychotropic substances. Therefore unless the rule is clear as to which schedule of drugs fall under a specific category, the manufacturers can be in trouble.

Further, control over the NDPS substance already exists in the Drugs & Cosmetics Act as Licence No.3 under Rule 37. The new procedure, unless it has some fresh and constructive provisions to control the misuse of NDPS, it will be an additional burden to the manufacturers of such drugs, says an expert.

"If the government wants to stop misuse of substances like codeine, they should ban such products. We can look for some synthetic derivatives as substitutes, which may have fewer side effects," said Manoj Tongra, drug control officer, Rajasthan and a legal expert. "For instance," he added, "an amino acid methionine hydrochloride IP could be a better substitute for codeine which does not have the side effect of habit formation unlike the latter molecule."

The current practice of allotting quota for the manufacturers of codeine preparations will only help to increase the tasks of the industry whereas the misuse will continue to happen in the retail level. It is necessary that the misuse of narcotic drugs and psychotropic substances by the public should be stopped but for that the government has to come up with effective regulations, an industry source said.

As per the new amendment, published as draft rules Drugs and Cosmetics (4th Amendment to Rules 2009) in mid June, the pharma companies which manufacture products using narcotic and psychotropic substances have to file application in Form 24G and 25G instead of Form 24.

The application will also be accompanied by a license fee of Rs 6000 and an inspection fee of Rs 1500 for every inspection or for the purpose of renewal of license. The new rule also asserts that the manufacturers should furnish various information regarding the purchase and usage of narcotic drugs and psychotropic substances to the CLAA at the time of applying for the licence.