Govt struggles to check spurious drugs

Absence of a strict monitoring mechanism and gaping holes in existing laws have helped the multi-crore business of spurious and adulterated drugs mushroom across the country.

New Delhi: Absence of a strict monitoring mechanism and gaping holes in existing laws have helped the multi-crore business of spurious and adulterated drugs mushroom across the country.
Sample this. There are only about 26 drug inspectors in the national capital to check on about 14,500 chemist shops in the city.

Experts say that the best possible ratio should be 1:60 whereas at present a drug inspector in Delhi keeps a check on about 550 chemist shops each.

The office of Drug Controller General of India, which has the mandate to approve new drugs licences, regulation of pharmaceutical imports besides acting as central licensing authority, has about 15 drug inspectors only.

Out of about 27 drug testing laboratories in the country, only about seven are believed to be well equipped and functioning effectively.

"The situation is alarming. Out of the 27 drug testing labs in the country, only seven are available for carrying out proper checks. There are shortfalls in the number of drug inspectors also. Ideally, the ratio between drug inspectors and chemists shops should be 1:60 but in our country the ratio is much more," Harinder Sikka, Director of corporate affairs at Piramal Healthcare, said.

He added, "The government has promised amendments in the
existing laws to check this menace and we hope the gaping holes in the present system are taken care of."
Industry sources said at present, a person convicted for manufacturing or selling spurious and adulterated drugs gets a maximum sentence of five years, "which is very less."

Moreover, the country`s ports, through which India last year had exported pharmaceutical goods of about Rs 35,000 crore, also lacks the necessary facilities to check if any such products are spurious or adulterated, sources in drug enforcement agencies said.

"The problem is that once a container is sealed and packed from one state, it is rarely checked when it reaches a port of another state," sources said.

They said at the time of import, even though drug enforcement agency officials are present, it is not mandatory that all pharma products pass through them.

"The Customs are concerned about the revenue part and whether the importer has the relevant licence. If not, then it is directed to us," sources said.

At the Chennai port last year, drug enforcement officials had come across three cases of illegal import of bulk drugs (2,900 kg) from China, all of which were seized.

"It can be done. The customs officials on the ground decides on the step to be taken depending on the gravity of the offence committed. Under the Customs law, there is penal provision, confiscation, redemption fine, penalty and even prosecution", Central Board for Excise and Customs Chairman P C Jha told media when asked if Customs have registered cases for prosecution against offenders in the recent past.

"We have requested the government that only those ports which have the facility to carry out checks on pharmaceutical products should be allowed to export it," Sikka said.

Industry as well as drug enforcement agencies said that lack of a Central Drug Control Authority was yet another roadblock, something which the Union Health and Family Minister Ghulam Nabi Azad has now proposed to set up.

"Even if a drug is not given a licence for instance in Delhi, the manufacturer can go to another state and get the job done. With this licence he can market his product throughout the country," sources said.

They alleged that the pharma industry too was to be blamed as many of them were yet to adopt scientific methods to check spurious or adulterated drugs.

Globally, pharma companies are now using technology like bar coding, radio frequency identification chips and innovative packaging designs to check counterfeit drugs.

Another, major drawback for enforcement agencies was the lack of official statistics on the actual spread of spurious or adulterated drugs.

Out of the total over Rs 85,000 crore pharmaceutical business in the country, Rs 17,000 crore is alleged to be that of spurious and adulterated drugs.

The government is currently carrying out a nationwide survey involving various NGOs to collect samples and test them to understand the real presence of the menace.

Bureau Report