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The much-discussed Jan Vishwas Bill, passed on 27 July, spurred a debate among health policy experts and activists for two amendments to the Drugs and Cosmetics Act, 1940 – with many pointing out it's potential implications.
According to some experts, the new amendments would end up 'decriminalising' certain offences linked to drug manufacturing in India.
"This Bill fulfills a long standing wish list of the industry that if you suffer bodily harm from substandard medicine, no one will be held punitively accountable," public health activist, Dinesh Thakur, said in a series of tweets critiquing the amendments.
Let's break down what's happening, and why experts are wary of these changes, and what has been the government's response.
Jan Vishwas Bill: ‘Why Lower Punishment for Substandard Drugs?’ Ask Experts
1. Jan Vishwas Bill: What Is the Amendment?
The Jan Vishwas Bill was drafted to amend 42 laws administered by 19 ministries. The objective behind the Bill is to do away with "outdated rules" of criminal punishment and imprisonment for several minor offences.
The Bill seeks to make two amendments to the Drugs and Cosmetics Act, of 1940 — the Act that regulates the import, manufacture and distribution of drugs in India.
Currently, the Act defines four categories of offences— adulterated drugs, spurious drugs, mislabeled drugs, and Not of Standard Quality drugs (NSQs) — and lays out degrees of punishment (a combination of prison time and fine) based on the degree of offence.
Section 27(d) specifically deals with offenses of misbranding and Not of Standard Quality Drugs (NSQs), which currently require up to two years of imprisonment and a fine of up to Rs 20,000.
The Jan Vishwas Bill essentially makes it so these offences under Section 27(d) can be converted into compoundable offences wherein the accused can avoid imprisonment, by paying a fine of up to Rs 5 lakhs.
Will Promote Business, but Is It Fair?
While introducing the Bill, union minister Piyush Goyal said the Bill was drafted because, "The fear of imprisonment for minor offences is a major factor hampering the growth of the business ecosystem and individual confidence."
Speaking to FIT, activist entrepreneur, and member of All India Drug Action Network (AIDAN), S. Sriinivasan, says, "minimizing the threat of imprisonment by possibility of compounding , a lot more young people may enter pharmaceutical manufacturing in India. A lot more 'operators' may come in too. It is interesting to see the Jan Vishwas Bill justifies the move at several places in terms of ease of business for foreign investors."
"But, it's difficult to say if the move is fair from the consumer's point if view," he adds.
"Decriminalisation should be the way forward, especially for petty offences. However, why the Drugs and Cosmetics Act finds a place in this Bill is not clear to me," says, Shreya Shrivastava, Senior Resident Fellow at Vidhi Centre for Legal Policy.
Expand2. Lower Punishment for Substandard Drugs?
"Even though it is not strictly 'decriminalising' it, compounding lessens the chances of a company getting the right punishment for making substandard drugs," says Parth Sharma, Fellow, Lancet Citizen’s Commission on Reimagining India's Health System.
Shrivastava points out that the upper limit of 5 lakhs for the fine doesn't pose as much of a deterrent. "It's such a small amount for big pharmacists, its very easily manageable," she says.
To make things appear murkier, experts say, the Union Ministry's press release makes it sound like substandard drugs are lesser offences.
What Did the Govt Say?
Following the backlash, the Union Health Ministry responded with a statement addressing these concerns.
The press release says, any drug which,
Proves to be injurious to health or may cause bodily injury or death
Contains toxic substances
Is manufactured in unsanitary conditions
Is manufactured in violation of any prohibitions
Has been manufactured without a license
Contains any substance to reduce its quality or strength
Is manufactured under a name which belongs to another drug
Is manufactured in violation of any prohibitions
... will not be covered under the proposed amendment, and will continue to warrant stringent criminal provisions.
Experts, however, are not satisfied with the claims in the press release, calling it 'misleading'.
Srivastava says that the government's response is also "very confusing" because it sounds like it's trying to downplay the actual implications of the amendments.
"The messaging is that there are spurious drugs, and other than that there are no issues in the drugs in India," says Shrivastava, adding that treating NSQ drugs with such leniency can lead to complacency and prove dangerous.
This is a problem because along with spurious drugs, India has also been grappling with a major challenge of sub-standard drugs.
"The amendment clearly says that contraventions of the act other than adulterated, and spurious drugs would automatically come under section 27(d) and can be compounded. But then, the Ministry gives a clarification that any drug that has failed the parameters, and has been identified to be injurious to health, or causing death, these offences cannot be compoundable."
"But this sort of fine print isn't part of the amendment itself, so it's a bit confusing, and not reassuring."
Shreya ShrivastavaExpand3. The Reputation of India-Made Drugs Still Hangs by a Thread
The Jan Vishwas Bill incidentally comes in the heel of a slew of international cases of quality issues linked to drugs manufactured in India.
At time when the Government is trying to clean up its act and reinstate trust in India-made drugs, experts say these changes could further hurt their reputation.
"It brings us one step back from where they were in terms of trying to save the reputation of Indian manufactured drugs because this gives the signal that we are clearly not interested in having stricter regulations when it comes to the standard of drugs manufactured in India."
Shreya Shrivastava, Senior Resident Fellow at the Vidhi Centre for Legal PolicySpeaking to FIT, Prof Bejon Kumar Misra, Founder at Patient Safety and Access Initiative of India Foundation, says, "What we need is more stringent regulatory oversight to ensure the licencing is done in a more transparent manner, in a more robust manner in every stage of the supply chain,"
A watertight framework for this is still missing in the document, he says.
Expand4. 'Stricter Regulations, But Imprisonment Not the Way'
While experts can agree upon the need for stricter regulations, Prof Misra says, more imprisonment isn't what they're lobbying for.
"The debate shouldn't even be about imprisonment vs fine," he says.
"As a representative of a patient organization, we are more interested in deterrent action by making the criminals pay hefty compensations to the patients who become victims of spurious medicines or low quality medicines in the country."
Prof Bejon Kumar Misra, Founder at Patient Safety and Access Initiative of India FoundationShrivastava also goes on to add that there are several issues with the existing drug regulations in India that need to be addressed but this Bill isn't really helping close any of those gaps.
For that, experts have their eyes on the amended The New Drugs, Medical Devices and Cosmetics Bill, 2023, which was put out last year, but hasn't yet got cabinet clearance.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)
Expand
Jan Vishwas Bill: What Is the Amendment?
The Jan Vishwas Bill was drafted to amend 42 laws administered by 19 ministries. The objective behind the Bill is to do away with "outdated rules" of criminal punishment and imprisonment for several minor offences.
The Bill seeks to make two amendments to the Drugs and Cosmetics Act, of 1940 — the Act that regulates the import, manufacture and distribution of drugs in India.
Currently, the Act defines four categories of offences— adulterated drugs, spurious drugs, mislabeled drugs, and Not of Standard Quality drugs (NSQs) — and lays out degrees of punishment (a combination of prison time and fine) based on the degree of offence.
Section 27(d) specifically deals with offenses of misbranding and Not of Standard Quality Drugs (NSQs), which currently require up to two years of imprisonment and a fine of up to Rs 20,000.
The Jan Vishwas Bill essentially makes it so these offences under Section 27(d) can be converted into compoundable offences wherein the accused can avoid imprisonment, by paying a fine of up to Rs 5 lakhs.
Will Promote Business, but Is It Fair?
While introducing the Bill, union minister Piyush Goyal said the Bill was drafted because, "The fear of imprisonment for minor offences is a major factor hampering the growth of the business ecosystem and individual confidence."
Speaking to FIT, activist entrepreneur, and member of All India Drug Action Network (AIDAN), S. Sriinivasan, says, "minimizing the threat of imprisonment by possibility of compounding , a lot more young people may enter pharmaceutical manufacturing in India. A lot more 'operators' may come in too. It is interesting to see the Jan Vishwas Bill justifies the move at several places in terms of ease of business for foreign investors."
"But, it's difficult to say if the move is fair from the consumer's point if view," he adds.
"Decriminalisation should be the way forward, especially for petty offences. However, why the Drugs and Cosmetics Act finds a place in this Bill is not clear to me," says, Shreya Shrivastava, Senior Resident Fellow at Vidhi Centre for Legal Policy.
Lower Punishment for Substandard Drugs?
"Even though it is not strictly 'decriminalising' it, compounding lessens the chances of a company getting the right punishment for making substandard drugs," says Parth Sharma, Fellow, Lancet Citizen’s Commission on Reimagining India's Health System.
Shrivastava points out that the upper limit of 5 lakhs for the fine doesn't pose as much of a deterrent. "It's such a small amount for big pharmacists, its very easily manageable," she says.
To make things appear murkier, experts say, the Union Ministry's press release makes it sound like substandard drugs are lesser offences.
What Did the Govt Say?
Following the backlash, the Union Health Ministry responded with a statement addressing these concerns.
The press release says, any drug which,
Proves to be injurious to health or may cause bodily injury or death
Contains toxic substances
Is manufactured in unsanitary conditions
Is manufactured in violation of any prohibitions
Has been manufactured without a license
Contains any substance to reduce its quality or strength
Is manufactured under a name which belongs to another drug
Is manufactured in violation of any prohibitions
... will not be covered under the proposed amendment, and will continue to warrant stringent criminal provisions.
Experts, however, are not satisfied with the claims in the press release, calling it 'misleading'.
Srivastava says that the government's response is also "very confusing" because it sounds like it's trying to downplay the actual implications of the amendments.
"The messaging is that there are spurious drugs, and other than that there are no issues in the drugs in India," says Shrivastava, adding that treating NSQ drugs with such leniency can lead to complacency and prove dangerous.
This is a problem because along with spurious drugs, India has also been grappling with a major challenge of sub-standard drugs.
"The amendment clearly says that contraventions of the act other than adulterated, and spurious drugs would automatically come under section 27(d) and can be compounded. But then, the Ministry gives a clarification that any drug that has failed the parameters, and has been identified to be injurious to health, or causing death, these offences cannot be compoundable."
"But this sort of fine print isn't part of the amendment itself, so it's a bit confusing, and not reassuring."Shreya Shrivastava
The Reputation of India-Made Drugs Still Hangs by a Thread
The Jan Vishwas Bill incidentally comes in the heel of a slew of international cases of quality issues linked to drugs manufactured in India.
At time when the Government is trying to clean up its act and reinstate trust in India-made drugs, experts say these changes could further hurt their reputation.
"It brings us one step back from where they were in terms of trying to save the reputation of Indian manufactured drugs because this gives the signal that we are clearly not interested in having stricter regulations when it comes to the standard of drugs manufactured in India."Shreya Shrivastava, Senior Resident Fellow at the Vidhi Centre for Legal Policy
Speaking to FIT, Prof Bejon Kumar Misra, Founder at Patient Safety and Access Initiative of India Foundation, says, "What we need is more stringent regulatory oversight to ensure the licencing is done in a more transparent manner, in a more robust manner in every stage of the supply chain,"
A watertight framework for this is still missing in the document, he says.
'Stricter Regulations, But Imprisonment Not the Way'
While experts can agree upon the need for stricter regulations, Prof Misra says, more imprisonment isn't what they're lobbying for.
"The debate shouldn't even be about imprisonment vs fine," he says.
"As a representative of a patient organization, we are more interested in deterrent action by making the criminals pay hefty compensations to the patients who become victims of spurious medicines or low quality medicines in the country."Prof Bejon Kumar Misra, Founder at Patient Safety and Access Initiative of India Foundation
Shrivastava also goes on to add that there are several issues with the existing drug regulations in India that need to be addressed but this Bill isn't really helping close any of those gaps.
For that, experts have their eyes on the amended The New Drugs, Medical Devices and Cosmetics Bill, 2023, which was put out last year, but hasn't yet got cabinet clearance.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)