Weak legislation, poor regulation of exporting countries, lack of cooperation between regulatory authorities, corruption and differences in interest, political reluctance, stipulation and high cost of medicines are the factors encouraging counterfeit and spurious drugs sale in the market, said Dr BR Jagashetty, drugs controller, Government of Karnataka.
Currently fake drugs are discovered through random sample collections by inspectors at the state drugs control departments during their surprise inspections of pharmacy outlets. At times complaints by aggrieved drug manufacturers also alert the drugs control offices about the sale of counterfeit and spurious drugs. However, these steps are inadequate to determine the presence of such drugs to control the problem, he said.
There is hardly any difference in the definition of a counterfeit and spurious drug. The former is produced by forging an original drug and carried out with a motive to deceive the consumers. The latter is manufactured under a name of a fictitious company.
The sale of spurious drugs has been remunerative for those engaged in its production. It is rampant primarily in cases where a small-scale pharma manufacture is not able to succeed in the competitive environ of reputed producers of generics leading to loss and revenue constraints. With 80 per cent of the Indian population in rural areas and with 50 per cent literacy, along with wide exposure to quacks for treatment, the counterfeit /spurious drugs are sold across the country.
In fact, the modus operandi is through recycling, refilling, imitation or production without knowledge of good manufacturing practices. These drugs are marketed by unlicensed manufacturers and stocked by unauthorized dealers, sold through fake bill transactions and prescribed by unqualified medical practitioners, said Dr Jagashetty in a presentation titled Challenges to Combat menace of counterfeit/ spurious drugs at the recent 3rd Annual Pharmaceutical Leadership Summit at Mumbai.
Inadequate infrastructure and paucity of inspectors are major factors driving the production and sale of counterfeit/ spurious drugs. Although the Task Force recommendation calls for one drugs inspector for 100 sales establishments and one drugs inspector for 25 production plants, the present strength is grossly inadequate. There is also the issue of agglomeration of pharmacy outlets in urban and semi urban locations also lead to unethical business.
Serious action against violators are not forthcoming primarily because of delayed court procedures and easy availability of bail, said Dr Jagashetty.
Karnataka is now the only state in the country which has set up 30 Special Courts at all its districts to undertake the trial of offences related to adulterated and spurious drugs as provided in the Drugs & Cosmetics (Amendment) Act 2008.
Under section 32B based on the Code of Criminal Procedure in the Drugs & Cosmetics (Amendment) Act 2008 on compounding of offences calls for imprisonment with fine. Under section 36 AB which calls for setting up a special court to undertake the trial of the offence, the central or state government in consolation with the chief justice of the High Court would carry out the examination of the offences related to spurious and adulterated drugs.
In February, the Centre had expressed its plan to set up special courts in Mumbai, Ahmedabad, Chandigarh, Chennai and Hyderabad. “There is need for a proactive role from the government, regulatory authorities and industry to combat the menace,” added Dr Jagashetty.