However, the notification presents just the opposite, which declares that the bill is being brought ‘to amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, safety, efficacy, performance, and clinical trial of new drugs and clinical investigation of investigational medical devices and for matters connected therewith or incidental thererto.’

The draft bill notified by the Ministry of Health and Family Welfare on July 8, 2022, says that review of obsolete laws and updating of the existing laws is a continuous process to accommodate changed requirements and adaptation of new technology. The government has time and again emphasized the need to review obsolete laws and to periodically repeal and amend laws. Since the Drugs and Cosmetics Act, 1940, was a pre-independence legislation enacted by the Central Legislative Assembly, the review and updating of Drugs and Cosmetics Rules, 1945 was vigourously taken up from the year 2016. And in the light of recommendations of the Central Government and the felt need to have comprehensive legislation, a committee was constituted for framing the draft of the new bill.

The proposed Draft New Drugs, Medical Devices and Cosmetic Bill, 2022 has been brought for the announced objective to keep pace with changing needs, times, and technology. Within less than a fortnight the MoHFW is likely to close its doors for suggestions, comments, and objections as it has notified 45 days for the purpose.

Nothing can properly be understood out of context, and this bill is also not an exception. Pharmaceutical industry has been demanding for a long time to “decriminalize” some of the offences under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, and also allow them to sell some of the drugs which have been declared “Not of Standard Quality” (NSQ) after failing in quality testing in accordance with standards published in the Indian Pharmacopoeia (IP) as per the standard laid down by the government body called the Indian Pharmacopoeia Commission (IPC).

If the drugs fail in quality testing as per standard laid down in IP, these deemed to fail in treating patient. The pharmaceutical lobbies have been telling the government that even some of the failed drugs will work. Surprisingly, the draft bill presumes the demand correct, or else it could not have attempted to push for the divisible concept that is “some drug will work even if it fails on certain quality parameters. Presently, when a drug fails in any of the parameters of quality, or the drug fails in treating patients, it is declared NSQ.

As per the present IP a drug is declared standard if the amount of active ingredient is in the range of 90 to 110 per cent of what is advertised on the label. However, one of the provisions (entry 4) of the fourth schedule, has lowered it to 70 per cent. It would certainly reduce the effectiveness of the drug, which will make the patients miserable and the time of recovery would be longer. In case of communicable disease it would have disastrous effect on public health. Not only this, the contamination of drugs, such as with heavy metals and other dangerous particulate mattes or even fungus etc is not dealt strictly in the draft bill, which will attract even reduced punishments both in terms of imprisonment and fine.

The new bill was drafted by a drafting committee headed by Drug Controller General of India (DCGI) and hence it is a matter of serious concern. It has already been alleged that DCGI is being influenced by drug, cosmetics, and medical device manufacturers lobbies at the cost of patients. There have been even corruption cases and arrests against several officials. Even one of the drafting committee members has tainted record and was even arrested.

As per the Drugs and Cosmetics Act, 1940, the production and sale of the NSQ drugs is punishable with minimum imprisonment of one and maximum two years with fine of Rs 20,000. The rationale behind criminalization was that the NSQ drugs have direct implications on health of the patients. Given the menace of spurious and NSQ drugs in India, in which patients have no only reported greatly suffering, and some of them even losing their lives, it was being expected that the Modi government would provide sufficient legislative protection to patients through enhancing punishment. However, the government has done just opposite, the punishment has been reduced.

The section 56(e) says that any drug deemed to be not of standard quality under section 34 or misbranded under section 35 and included in the Fourth Schedule or in contravention of any other provision of this chapter or any rule made under this Act, shall be punishable with imprisonment for a term which may extend to one year or with fine which shall not be less than two lakh rupees. It should also be noted that presently, the defects not falling in the fourth schedule, is punishable for up to two years of imprisonment and a fine of five lakh rupees.

Manufacturers have been favoured against the patients in several ways. For example, another section 71, makes the offence compoundable and the offenders may go scot-free after paying some money. Section 71(1)It says notwithstanding anything contained in the CrPC 1973, any offence punishable under clause (f) of section 27, clause (e) of section 56, clause (b) of section 57, section 59, section 60, and clause (b) of section 79 and section 81 of this Act (whether committed by a company or any officer thereof), not being an offence punishable with imprisonment only, or with imprisonment and also with fine, may be compounded, by DGCI, or State Drugs Controllers, on payment for credit of such sum and in such manner as may be prescribed.
Section 71(2) further says that where an offence is compounded under sub-section 71 (1), no proceeding or further proceeding, as the case may be, shall be taken against the offender in respect of the offences so compounded and the offender, if in custody, shall be released forthwith.

The 43 exceptions for defects listed in the fourth schedule for declaring NSQ, has also been made subject to the power of the government under section 58 of the bill, which may extend the number of exception if it desire so. The provision is dangerous given the powerful lobbying activities and susceptibility of the running political establishments.

The draft contains numerous other defects and hence, it should either be scraped or reframed. Better option is to strengthen the Drugs and Cosmetics Act 1940 to protect individual and public health at a time when the world is undergoing several health hazards.