Due to zero accountability on the side of manufacturing companies in withdrawing not-of-standard quality (NSQ) drugs from the market, the Indian pharma market is flooded with NSQ and sub-standard drugs, which are beyond the control of regulators.

Marketing companies are forced to promote the same batches in various parts of the country, and some manufacturers allegedly influence laboratory officials to delay the test reports in order to have a time to sell out the finished formulations.

This is unfair as well as unethical business practice which occurs in the pharma market every time due to lack of provisions for control in Drugs and Cosmetics Act which needs to be amended for effective recalling of NSQs promptly, according to Revi S. Menon, deputy drugs controller, government of Kerala.

“There is gigantic quantity of NSQ drugs in the Indian pharma market. They are marketed in several places by separate marketing companies. Most of these drugs are manufactured in the excise free zone areas in Uttharakhand and Himachal Pradesh. Those manufacturers should be accountable for withdrawing the batches immediately from the market. The state and central law enforcing agencies are helpless in weeding out these batches from circulation or imposing any fine on the manufacturers due to lack of adequate provisions in the law,” he says.

Talking to Pharmabiz, the regulatory officer said a drugs control department of a state in India has issued one circular about a drug which was found as NSQ in their lab test. But, the same batch of the drug was available in the market for sale in Kerala for a long time after it was declared as NSQ. This happened because the manufacturing company has not withdrawn the product from sale soon after it was found NSQ in the laboratory test. Had there been a provision in the D&C Act to punish the manufacturer for delaying recall of the drug, the product would not have been promoted in any other state in the country. So, the Act should be amended to include a provision to inflict penalty upon the erring manufacturers in this regard, he added.

Similarly, there should be tough provisions to bar the marketing people from promoting the drugs declared as NSQs by a regulatory body. The regulatory officials, when lift samples from a medical shop, may not know whether they are NSQ or not. They may not always possess the test reports of different laboratories. But it is occurred that one drug, found as not-of-standard-quality, is being sold in other areas in the same state itself. The persons responsible for this unfair business practices are the manufacturers only, not the marketers, because they are not the licensed people.

When asked about the operation of unlicensed marketing people in the drug sale domain, Revi Menon said in India there is no centralized or state wise registry to find how many marketing companies are in the field. This is because they do not need endorsement for marketing by the regulatory body. The drugs control department of a state does not have the details of marketers and of their promotional activities. This unethical business practice should be thwarted immediately, for which the Drug Controller General of India (DCGI) and the Union health ministry should contemplate for solution.