Some chalk for your fever?

PIL was filed this week on fake drugs, which are 20 of pharma turnover. Yet public energy is mostly spent on drug prices

A drag is anything that alters the body8217;s biological functioning. Stated thus, a drug need not be synthetic and the dividing line between drug and food becomes thin. Is insulin produced naturally in the body a drug, or does a substance become a drug only when it is introduced into the body? As in other countries, one needs a legal definition of a drug and that8217;s precisely what Indian laws have tried to do, with Opium Act 1878, Poisons Act 1919, Dangerous Drugs Act 1930, Drugs Act 1940, Drugs and Magic Remedies Act 1954 and Narcotic Drugs and Psychotropic Substances Act 1985. However, the core drug definition is in Drugs Act 1940, later amended to Drugs and Cosmetics Act 1962. Thus drug 8220;includes 8212; i all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; ii such substances other than food intended to affect the structure or any function of human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; iii all substances intended for use as components of a drug including empty gelatin capsules; and iv such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government8230;8221;

The registration system for drug manufacturers is also courtesy Drugs and Cosmetics Act DCA. If one does a net search on the number of manufacturers in India, the figure is likely to be around 20,000, a number that8217;s regarded as gospel truth. Five years ago, people would probably have said 25,000, some manufacturers having been weeded out because of competition and implementation of an improved schedule on good manufacturing practices. People are falling over backwards to disown Dr R.A. Mashelkar now. There have been several Mashelkar Committees. Like the Chopra Committee, 1931, that led to the Drugs Act in 1940, the Mashelkar Committee of 2003 is likely to have an enormous impact on India8217;s drug regulatory system, if recommendations are ever implemented. The Mashelkar Committee had a more conservative estimate on the number of drug manufacturers 8212; 133 for bulk drugs, 4,534 for formulations, 134 for large-volume parenterals, 56 for vaccines a total of 5,877 for bulk drugs/formulations, 199 for medical devices, 638 for surgical dressings, 272 for disinfectants, 318 repacking units and 2,228 for cosmetics. Note that DCA also covers ayurvedic, unani and siddha systems of medicine and homoeopathy. Drug manufacturers, in the sense we usually understand them, probably number 6,000.

Even that8217;s a colossal figure and includes manufacturers operating out of garages. Whenever pharmaceuticals are mentioned, people think of large multinationals and images of big bad Tyrannosaurus Rex, with monopolies, entry barriers, patents and high prices. However, the smaller, nimbler Velociraptor can be no less vicious. Enforcement is a serious problem with a large number of scattered and small manufacturers. Chalk is used instead of paracetamol. Tap water masquerades as adrenaline. Ingredients are used in lower-than-recommended potencies. Legally, there are four different kinds of crimes: sub-standard, misbranded, adulterated and spurious drugs. In each case, the offending drug costs less than the genuine article. If health is important enough for us to get upset about high prices, shouldn8217;t we be equally upset about inferior quality? Or do low prices justify everything? That seems to be the thrust in government procurement through L1 quotations.

The figures are scary. Of the total annual pharma turnover of Rs 20,000 crore, Rs 4,000 crore is estimated to be spurious all four varieties. The media routinely cites a WHO report to the effect that 35 per cent of the world8217;s spurious drugs are manufactured in India, though WHO denies having said this. But we do know that several trading partners including the US have complained about India exporting spurious drugs. Reportedly, only 23 states have testing labs and only seven of these are functional and capable of testing all varieties of drugs. There are 935 drug inspectors and 3,00,000 sales units that have to be inspected every year, 320 per inspector. One can imagine the kind of inspection that takes place.

The Mashelkar Committee 2003 went into these legal, regulatory and systemic problems. After a PIL in July 2003 filed by PUCL, Delhi High Court instructed the government to take action on spurious drugs. The interim report of the Mashelkar Committee followed in August 2003 and the final report in November. In December, a bill to amend DCA was introduced in Lok Sabha, but Parliament was dissolved. In May 2005, another bill was introduced, this time in Rajya Sabha. The Parliamentary Standing Committee on Health and Family Welfare submitted its report to both Houses in December 2005. There the matter rests. The government8217;s asleep. How dare one mention Mashelkar any more? What happens to job losses among spurious drug manufacturers? Perhaps one should incorporate spurious drug manufacture as a recognised activity under the National Rural Employment Guarantee Act. If one is lucky, executive somnolence is sometimes stirred through PILs. Last week, Delhi High Court has admitted a PIL against the government on non-implementation of the Mashelkar Committee recommendations.

At home, we recently ran out of gas and the legitimate supply of a cylinder would have resulted in a week8217;s wait. So my wife collared a gas delivery man and obtained an out-of-turn cylinder with a premium of Rs 50. It lasted for a couple of days, because while there was some gas at the top, the rest of the cylinder was full of water. It seems to me that there ought to be a big difference between cooking gas and life-saving drugs.

The writer is an economist