New Drugs and Cosmetics Bill Dilutes Penalty

Laws are sometimes passed without proper debate in Parliament, so Congress launched a “Halla Bol” campaign in Delhi alleging that the opposition’s awkward questions inconvenienced the government which was lenient towards those who lined their coffers. And the pharmaceutical industry may have succeeded in pressuring the government to pass a watered-down law that allows drugmakers to gamble with the health of more than a billion citizens.

A new bill released by the Union Department of Health and Family Welfare that will replace the outdated Drugs and Cosmetics Act (DCA) of 1940 appears to benefit big pharma at the expense of sick citizens who need health insurance. The new bill has diluted the tough criminal provisions needed to jail those who attenuate their drugs by reducing the drugs active ingredient. This means that those expecting to be cured will not be cured immediately unless they swallow more tablets – more frequently.

The teeth of any law are the established rules by which the law is implemented and in the old law the Drugs and Cosmetics Rules, 1945 enacted under the DCA classified all drugs under various schedules with guidelines for their storage, sale, display and prescription under each program.

But what the government has not disclosed to the public is that the eight-member committee that drafted the new bill included a senior official who was arrested for alleged corruption. It is like former Medical Council of India (MCI) which was replaced by National Medical Commission because former MCI Chairman Dr. Ketan Desai who even contested the post of Chairman of the World Medical Association, was imprisoned by the CBI. after finding 1.5 kg of gold and 80 kg of silver at his home on April 22, 2010.

The MCI was disbanded on May 15, 2010 because previously a few of its members who visited new medical schools received “gifts” to recognize certain medical schools that produced medical waste. Similarly, chapter V of the new bill proposes scientific research advice to develop medicines for ayurveda, siddha, sowa-rigga (whatever that may mean), unani and homeopathy who practice all divergent medical systems, different from allopathy which has its pros and cons. .

The new bill assumes that a drug will cure a patient even if it fails to meet vital quality parameters. Either a drug conforms to the minimum quality standards set by a government body called the Indian Pharmacopoeia Commission which publishes these standards in the Indian Pharmacopoeia (IP), or the drug does not cure the patients. There is no third alternative.

Drugs that failed to meet the standards prescribed by the PI in the past were declared non-standard quality (NSQ), making the manufacturer liable to a jail term of one to two years longer. a fine of Rs 20,000 with special exceptions. Drugmakers should be jailed if they tamper with the active ingredient in their drugs because they harm the health of 1.5 billion Indians.

Section 56(e) of the new bill proposes to reduce penalties 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 punishable by imprisonment of less than one year only and a fine of Rs 200,000, while for other defects which do not fall under the fourth schedule, the manufacturer may be imprisoned for two years plus a fine maximum of Rs 500,000. But that is after their drugs have been sent for quality testing and proven beyond reasonable doubt to lack therapeutic efficacy – which, in simple terms , means they can’t heal you.

All of these aside, the real purpose and purpose of the revamped law is buried in Section 71 which makes up for a category of offences, including the defects of the Fourth Schedule. Compounding is a legal term that means the violator will escape prosecution and imprisonment after paying a fine, so the maker does not carry the stigma of being convicted after a trial.

It implies that the government succumbed to pressure tactics from the multi-crore pharmaceutical industry to decriminalize its heinous crimes, just as the Supreme Court ruled in 2005 that a doctor could not be sued for negligence simply because he there was an alternative choice of drugs or better treatment. He had to be guilty of “gross negligence”, whatever that meant.

IAS officer PC Singhi has died of frustration after fighting an alleged negligence case all the way to the Supreme Court for 20 years after his wife Leela Singhi died due to alleged negligence on the part of a leading doctor who was exonerated by the superior court.

Going back to the new bill, section 58 allows the government to expand the list of exceptions in the fourth schedule that allows big pharmaceutical companies to tamper with the active ingredients of their therapeutic drugs. The pharmaceutical industry has enormous leverage with the government which it will use to force the government to add more exceptions to the already existing 43 dangerous ones, so those who break the law can get away with it if they fall foul. of these 43 exceptions.

Intellectual property allows a drug to be declared of standard quality if its active ingredient is between 90% and 110% of what the label claims. But in the new law, entry 4 of the fourth schedule states that as long as the drug contains at least 70% of the advertised amount, the manufacturer will not be subject to a two-year prison sentence.

If a drug contains only 70% of the active ingredient, it will upset the doctor’s expectations when prescribing a drug, as the patient will never recover from an infection, but will also infect others with resistant bacteria to antibiotics.

In 2012, the Parliamentary Standing Committee on Health made the same accusation against the Central Organization for the Control of Medicines Standards, led by the DCGI. The link between the government and the drug manufacturers is now a closed circle like the link between doctors and the pharmaceutical industry, so each protects the other. The victims are the unfortunate 1.5 billion Indians

The author holds a doctorate in law and is a senior journalist and barrister at the High Court in Bombay.