As usual, the Government is always in denial about the size of spurious medicines. The Union Ministry of Health and Department of Pharmaceuticals maintain that according to a national survey by the Government in 2009, the percentage of spurious drugs was 0.046 per cent. However, media put it to 25 per cent. Following delicensing of pharmacy industry, manufacturers are free to produce any drug duly approved by the Drugs Control Authority. In the prevailing atmosphere, spurious drug industry is thriving with impunity, with corrupt and conniving elements in the official enforcement agencies.
About measures taken for ending the menace of spurious medicines in the country, official sources in the Government said amendment to the Drugs & Cosmetics Act (DCA) has been effected to provide for stringent penalty, life long imprisonment and Rs.10 lakh fine.
The DCA is to be amended further to provide for a chapter on clinical trials, the sources added. Other steps taken include a whistle blower scheme in the Central Drugs Standards Control Organisation (CDSCO) for ending dangers from spurious drugs, Guidelines to State Drugs Controllers for implementation, instructions to state inspectorate staff to keep proper vigil, and promotion by the Union Health Ministry of medicines by their generic names to ensure availability of drugs at affordable prices.
Some other measures taken include a mechanism in place to check misuse of clinical trials, provision of National List of Essential Medicines (NLEM) for regulating prices of medicines including those in the NLEM, a mechanism for controlling prices of drugs by the Department of Pharmaceutical (Ministry of Chemicals & Fertilizers), besides the Drug Prices Control Orders, 1995 (DPCO), and the National Pharmaceutical Pricing Authority. The Government also intends to amend the Indian Penal Code, 1860 to include spurious drugs as a non-cognizable offence , and make mandatory prescription for generic drugs, as in developed nations, to control and reduce prices. The Government has already launched a National Pharmocovigilance Programme (NPP) to create public awareness and to provide for checks and balance on clinical trials for medicines. States and Union Territories have set up special courts for trial of spurious drug cases. Efforts are on for expeditious investigation for speedy trial and punishment to the culprits in the business of imitation drugs.
Fight against spurious and imitation drugs is a long drawn war against the illegal trade of such drugs. Solution depends on the will and competence of the Government authorities. As long as the corrupt officials in the Government, who are well entrenched, connive with illicit drug manufacture and sales of such drugs, the menace will continue unabated!
MENACE OF SPURIOUS DRUGS IN INDIA
M.Y.Siddiqui - 2017-02-06 12:11
Spurious drugs are life threatening and not life saving. Menace of spurious drugs has spread like wild fire in the country. According to a World Health Organisation (WHO) report, 35 per cent of world’s spurious drugs are produced in India followed by Nigeria (23 per cent). It’s fallout is devastating on health of the common man. Simultaneously, reusage of drugs that are expired and tendency to rope in cheaper substitutes of certain drugs are malpractices going up at a fast pace. As per current estimates, market shares of spurious drugs are 20 per cent of total drug market of about Rs.5000 crore in India. Exporting such medicines is spreading menace further. Added to this, hospitals and pharmacy companies charge exorbitant price from their principal clients for trials on poor patients being subjected to high risk therapies resulting in severe side effects. Hospitals also claim tax benefits for such services.