The widespread manufacture and sale of spurious drugs in India places every member of the general public at serious risk to their life. According to several reports, out of the approximately Rs19,000 crores worth of business annually in the pharmaceutical sector in India, approximately Rs4,000 crores is on account of spurious drugs alone.
This exposes us to the very dangerous possibility of consuming fatal sub-standard drugs. The menace of spurious drugs violates the fundamental right to life guaranteed under Article 21 of the Constitution.
Among the spurious drugs commonly found in the market in India are fake insulin which may be taken by an unsuspecting diabetic, fake chemotherapy that may be administered to a final-stage cancer patient, the use of chalk instead of paracetamol in painkillers, or the use of tap-water presented as adrenaline, which may be used in an attempt to revive a patient who has suffered cardiac arrest, without any effect until it is too late.
Other spurious drugs contain the active ingredient in a lower potency level, while the end consumer may pay for normal potency, resulting in substantial profit margin for the manufacturer and seller.
Sub-strength spurious drugs such as anti-malarial drugs not only fail to cure but over time, create resistance in the malarial parasite with disastrous consequences for the patient.
The menace of spurious drugs is largely unchecked because of major inadequacies and lacunae in the existing regulatory scheme. These lacunae were recognized by this Hon’ble Court in its judgement and order date 30.7.2003 in People’s Union for Civil Liberties vs. Union of India and Ors. 105 (2003) DELHI LAW TIMES 937 (DB) wherein it observed at para 54:
“Unfortunately a very big market of spurious drugs is flourishing in our country. Guilty people who play with the lives of millions are rarely brought to books. It is unfortunate that no action is taken against them... .”
The penalties and provisions existing under the Drugs and Cosmetics Act, 1940 are ineffective. One of the reasons for the existing penalties not being effective is that the manufacture and sale of spurious drugs is primarily a clandestine activity which is showing increasing involvement of organized crime in recent years.
Besides, offenders are able to easily obtain bail as the offences are non-cognizable and bailable under the existing provisions of the Act. The offenders remain on bail due to delay in disposal of cases for manufacture and sale of adulterated and spurious drugs.
The Central Government constituted an Expert Committee under the chairmanship of Dr. R.A. Mashelkar, Director General of Council of Scientific and Industrial Research in January, 2003 to undertake a comprehensive examination of drug regulatory issues, including the problem of spurious drugs and to evaluate the extent of the problem of spurious drugs and recommend measures required to deal with the problem effectively.
The Committee, in its report of November 2003, inter alia, recommended that penalties be enhanced, a Special Court be designated for the speedy trial of spurious drugs cases, offences relating to spurious drugs be made cognizable and non-bailable and the police be authorized to initiate prosecution for offences related to spurious drugs.
However, more than three years after the date of the said Report, none of its recommendations have been implemented by the Respondents. This state of affairs constitutes a violation of the fundamental right to life guaranteed under Article 21 of the Constitution.
By way of the present petition in public interest, the Petitioner is, inter alia, seeking to enforce the fundamental right under Article 21 by way of issuance of directions to the Respondents to fill the lacunae in the regulatory scheme in respect of spurious drugs by implementing various recommendations of the Mashelkar Committee Report dated November 2003, more clearly detailed hereinafter, to secure a more effective, stringent and efficacious regulatory scheme to tackle the growing menace of spurious drugs in the country.
The Petitioner is also seeking the framing of guidelines setting stringent quality control standards in the prevailing governmental drug procurement policy and practice which is vital to save lives endangered by the spread of spurious drugs. The government, under its current drugs procurement policy, buys life saving drugs on the basis of lowest quotations (L I) and not necessarily high qualitative standards, as a result of which scores of government - run dispensaries and hospitals are flooded with spurious or sub-standard drugs.
The rates quoted by these so-called pharma companies are sometimes much lower than even the basic costs of raw materials. Many established pharmaceutical companies have even stopped bidding for government procurement orders for this reason, which allows a free hand to manufacturers of spurious drugs to pump large volumes of such drugs into the market, with tragic consequences for the general public.