A number of sterner measures including enhancement of the punishment and creation of intelligent-cum-legal wings in States and zonal offices are being planned the Central government to check the growth of spurious drugs in the country.
As per the proposals with the Centre, restrictions in licensing of retail pharmacies and limiting of restricted licenses to rural areas are also under consideration.
Creation of a central registry for formulations under the brand names and their compositions, appointment of nodal officers in each State and zonal offices for communications regarding spurious and counterfeit drugs and strengthening of the infrastructure are some other proposals being mooted.
According to a recent study by the Assocham, the spurious drugs market in the country has grown to Rs 400 million as of now, from the Rs 300 million mark of 2005. The study found that 20 per cent of the medicines sold in the country are fake. While 20 per cent of spurious drugs goes to the market unchecked due to the lack of preventive legislation, while 60 per cent of them are without active ingredients.
About 19 per cent have wrong ingredients while 16 per cent have harmful and inappropriate ingredients.
Counterfeit medicines in government hospitals are roughly at 38 per cent, while 35 per cent of fake drugs sold worldwide are sourced from India, the study said.
The Planning Commission in its report for the 11th Plan period has noted that lack of adequate number of inspectors, laboratories and testing facilities, insufficient funds, lack of facilities for speedy communication and mobility, and lack of enough training and investigation skills of the officials contributed to the spread of spurious drugs.
Lack of summoning powers to the inspectors was another reason for the menace, the Planning Commission said while suggesting special courts for speedy trials and uniformity in implementation and procedures in licensing.
The proposed amendment to the Drugs and Cosmetics Act also provides sterner punishment for the first offence in respect of adulterated or spurious drugs. As per the Clause(a) of Section 27, the bill proposes to punishment of death or imprisonment for a term which shall not be less than 10 years which may be extended to life term and Rs1 lakh or three times the value of drugs confiscated, whichever is more, as penalty. At present, the maximum term is five years, which may be extended to life term and fine of not less than 10,000.
The change incorporated in the bill also calls for provisions to pay the fine to the person who used such adulterated drugs and also punishment for the seller of the product.