THURSDAY, MAY 09, 2024
Gladstone D’Costa
The Jan Vishwas (Amendment of Provisions) Bill, 2023 has now been passed by both houses of parliament. As per the Committee which reviewed the bill there are three broad principles followed in the amendments which were recommended in the bill. The bill aims at giving further boost to ‘Ease of Living and Ease of Doing Business’. First, the provision of fine for offences of minor nature has been substituted with a monetary penalty to avoid involvement of Courts and to ensure “ease of living and doing business”. Second, provisions where both imprisonment and fine were prescribed have been reviewed and in most cases, they have been substituted with a monetary penalty. In some cases where the minor offences are of violations affecting public interest, the penalty of imprisonment along with fine has been retained with lesser duration. Third, provisions involving significant public interest where amendments for removal of imprisonment or doing away with fine have been proposed, are reviewed and imprisonment and fine have been retained or made harsher viz-a-viz the existing Act. The bill decriminalises about 180 minor offences across 42 central laws spanning pharma, media, agriculture, the environment and industry. It converts several fines to penalties which will lead to de-clogging of courts. While a fine is imposed by a judicial mechanism and one has to go to a court, a penalty can be levied through the administrative mechanism. By converting or ‘compounding’ prison sentences into fines and penalties, the new law will ‘enable businesses to breathe freely.’ Therefore, sections 32B (1) and 30(2) of the Drugs and Cosmetics Act; and Section 42(2) of the Pharmacy Act have been scrapped or altered.
This will have serious impact on the D&C Act, 1940, and its amendments; especially in view of the recent and on-going cough syrup scandal which has killed a large number of children across the world. Drug makers in India were ordered to stop the manufacture of the cough syrup after Indian origin samples were tested in countries like Gambia, Uzbekistan, Marshall Islands, Vietnam, Cambodia, Iraq, Georgia, Ghana, India, Cameroon and Kenya to name a few. These events have seriously damaged the image of India as the ‘pharmacy of the world’, with an industry worth about $41 billion. Recent risk-based inspections of 162 factories and 14 public laboratories found issues including ‘poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation, and absence of internal product quality review’, it said in a statement.
It also flagged an absence of raw materials testing, lack of measures to avoid cross contamination, absence of professionally qualified employees, and faulty design of manufacturing and testing areas. The ministry said it has upgraded ‘Good Manufacturing Practices’ under the Drugs and Cosmetics Rules to check the deficiencies found during the inspections. The upgrade includes the introduction of quality risk management, product quality review, supplier audit and approval, and validation of equipment. Large drug makers have been given six months and small manufacturers 12 months to transition to the upgraded manufacturing requirements, the ministry said. High NSQs (Not of Standard Quality) were found in the National Drug Survey 2014-16, conducted by the Health Ministry in drugs like erythromycin (29 per cent), gentamicin (21 per cent), amikacin (19.5 per cent), ORS (12 per cent) and pantoprazole (11 per cent). Eye drops too are suspect.
The Jan Vishwas Bill will only make matters worse by reducing the power of punitive measures for violating the drug standards in this country and endangering lives across the world. It will also sabotage the attempts of CDSCO to enforce compulsory bar coding on all batches of 300 drug brands to permit authentication of drugs. The government in its defence has issued a statement that the Jan Vishwas bill will only “decriminalise minor offences”. The definition of the current four categories of offences in the D&C Act, pertaining to drug quality has always been problematic. The current categories are, adulterated drugs, spurious drugs, misbranded drugs and NSQs’. However, the legal definitions for each of these remains complicated and porous.
Adulterated drugs as under sections 17(A,) 27(a) and 27(b) are those containing noxious substances or produced under unsanitary conditions. Spurious drugs are, in simple terms, counterfeit drugs. Misbranded drugs are those which are not labelled in the correct manner or physically altered to convey greater therapeutic value. And finally, NSQ drugs are those which fail to meet quality standards as laid out in Section 16 and the Second Schedule of the D&C Act. The Jan Vishwas Bill converts all offences punishable under section 27(d) into compoundable offences, meaning that the accused can escape jail time upon payment of a fine of Rs 20,000. Section 27(d) is the most frequently invoked provision by drugs inspectors in India. The ministry of health and family welfare implies that manufacturing NSQ drugs is not a serious offence. This is just not true. NSQ drugs can have serious consequences including death, due to failure of treatment, and can hardly be described as a minor offence punishable with a fine and not imprisonment. The public must be protected against those seeking to make a fast buck at the cost of a person’s health, and the leniency of the Jan Vishwas is grossly misplaced as far as healthcare is concerned. There are many court judgments to underline this, as the authors of “The Truth Pill: The Myth of Drug Regulation in India” point out. (State v. Iatros Pharmaceuticals Pvt. Ltd & Others, 2006, State of Maharashtra v. Olcare Laboratories, 2016)
The counter argument that the fear of imprisonment for minor slips could deter bonafide industry entrants just cannot be justified in a matter that endangers the lives of the common man. The government must rethink its misplaced attempts to reduce the judicial workload at the cost of diluting healthcare laws that protect the common man from the greed of pharmaceutical companies.
(The writer is a founder member of VHAG)
