Laws are sometimes passed without adequate debate in Parliament, which is why the Congress launched a ‘Halla Bol’ campaign in Delhi alleging the Opposition’s inconvenient questions were inconveniencing the government which was lenient towards those who filled their coffers. And the pharmaceutical industry may have succeeded in pressurising the government to pass a diluted law which allows drug manufacturers to play with the health of over one billion citizens.
A new Bill published by the Union ministry for health and family welfare which will replace the obsolete Drugs and Cosmetics Act, (DCA), 1940 appears to benefit big pharma to the detriment of ailing citizens in need of medicare. The new Bill has diluted the stringent penal provisions needed to jail those who attenuate their drugs by reducing the active ingredient in medicines. This will mean that those who expect to be cured will not be immediately cured unless they swallow more tablets--more frequently.
The teeth of any Act is the rules made by which the law is implemented and in the old law, the Drugs and Cosmetics Rules, 1945 enacted as a part of the DCA, classified all drugs under various schedules with guidelines for their storage, sale, display and prescription under each schedule.
But what the government has not disclosed to the public is that the eight-member committee which drafted the new Bill included a senior bureaucrat who was arrested for alleged corruption. This is like the erstwhile Medical Council of India (MCI) which was replaced by the National Medical Commission because the former MCI President, Dr Ketan Desai, who even contested for the post of the president of the World Medical Association, was jailed by the CBI after it found 1.5 kgs of gold and 80 kgs of silver at his home on April 22, 2010.
The MCI was dissolved on May 15, 2010 because earlier a few of its members who visited new medical colleges were given ‘’gifts” to recognise some medical colleges which produced medical garbage. Similarly, chapter V of the new Bill proposes a scientific research board to develop drugs for ayurveda, siddha, sowa-rigga (whatever that might mean), unani and homoeopathy which all practice divergent medical systems, different from allopathy which has its benefits and demerits.
The new Bill presumes that a drug will cure a patient even if it fails on vital quality parameters. Either a drug complies with the minimum quality standards laid down by a government body called the Indian Pharmacopoeia Commission which publishes these standards in the Indian Pharmacopoeia (IP), or else the drug fails to cure patients. There is no third alternative.
Drugs which have failed to meet the standards prescribed by the IP in the past were declared Not of Standard Quality (NSQ), rendering the manufacturer liable to be jailed between one year and two years plus a fine of Rs 20,000 with special exceptions. Drug manufacturers have to be jailed if they fiddle with the active ingredient of their drugs because they are trifling with the health of 1.5 billion Indians.
Section 56(e) of the new Bill proposes lowering punishments for drugs that have been declared NSQ due to any of the 43 defects listed in the fourth schedule of the Bill so that manufacturers are liable for a lower jail term of just one year and a fine of Rs 200,000, while for other defects that do not fall within the fourth schedule, the manufacturer can be jailed for two years plus a maximum fine of Rs 500,000. But that is after their drugs are sent for quality-testing and it is proved beyond reasonable doubt that they lack therapeutic efficacy — which in simple words means they cannot cure you.
All these apart, the true aim and object of the revamped law is buried in section 71 which allows for compounding for a class of offences including those defects in the fourth schedule. Compounding is a legal term which means the offender will escape being prosecuted and jailed after paying a fine, so the manufacturer does not carry the stigma of being convicted after a trial.
This implies that the government has succumbed to the pressure tactics of the multi-crore pharma industry to decriminalise its heinous offences just as the Supreme Court ruled in 2005 that a doctor could not be sued for negligence just because there was an alternative choice of drugs or better treatment. He had to be guilty of “gross negligence” whatever that meant.
An IAS officer, PC Singhi, died in frustration after battling an alleged negligence case all the way to the Supreme Court for 20 years after the death of his wife Leela Singhi due to alleged negligence on the part of a top doctor who was exonerated by the top court.
To return to the new Bill, section 58 allows the government to expand the list of exceptions in the fourth schedule which permits big pharma to play around with the active ingredients in their therapeutic drugs. The pharma industry has enormous clout with the government which it will use to force the latter to add more exceptions to the 43 dangerous ones already existing, so that those who violate the law can get away if they fall under these 43 exceptions.
The IP allows a drug to be declared of standard quality if its active ingredient ranges between 90 per cent to 110 per cent of what the label proclaims. But in the new law, entry 4 of the fourth schedule declares just as long as the drug contains at least 70 per cent of the advertised amount, the manufacturer will not face a two year jail term.
If a drug has only 70 per cent of the active ingredient, this will play havoc with what the physician expects while prescribing a drug, because the patient will never recover from an infection but also infect others with bacteria which resist antibiotics.
In 2012, the Parliamentary Standing Committee on Health had levelled this same charge against the Central Drugs Standard Control Organisation, which is headed by the DCGI. The nexus between the government and the drug manufacturers is now a closed circle like the nexus between the doctors and the pharma industry, so that each protects the other. The victims are the hapless 1.5 billion Indians
The writer holds a PhD in law and is a senior journalist and advocate at the Bombay High Court