A critical lapse in Jan Vishwas Bill

In seeking to make life easier for entrepreneurs, the proposed new law raises several questions on patient safety

Last week, the Lok Sabha passed the Jan Vishwas (Amendment of Provisions) Bill. The Rajya Sabha is also likely to give its assent to the Bill soon. According to the Press Information Bureau release, the Bill aims to further boost the ease of living and ease of doing business by proposing to amend 183 provisions to decriminalise 42 Central Acts administered by 19 ministries.

When this Bill becomes a law, it will make life easier for entrepreneurs in several businesses, the pharmaceutical industry being one of them. Some of the changes in the Drugs & Cosmetics (D&C) Act due to the Jan Vishwas legislation will be welcomed by drug makers, but Indian consumers of medicines may not have as much to cheer about.

Before the Bill came up for voting in the Lok Sabha, the Indian drug industry’s manufacturing and quality control practices had come under harsh scrutiny.

• In late April this year, the Central Drugs Standard Control Organisation’s latest round of inspections found 48 commonly used and well-known brands, including antacids, antibiotics, and blood pressure lowering drugs, to be substandard.
• The US Food and Drugs Administration (FDA)  had also pulled up several of India’s prominent drug manufacturers that were exporting generics to the US. It pointed to multiple problems in factories making these generics — ranging from unsanitary manufacturing conditions, contaminated drugs, and shredded paperwork.
• Moreover, there were reports of deaths of children in Gambia and Uzbekistan linked to cough syrups made by an Indian manufacturer. A task force formed by the Gambian President Adama Barrow has recommended suing not just Maiden Pharma — the firm that made the contaminated cough syrups — but also the Indian government.
• Meanwhile, Sri Lanka has announced that it will not buy eye drops manufactured by an Indian firm in Gujarat because they were linked to vision loss. Even earlier, Nepal had blacklisted 16 Indian drug firms for the bad quality of their medicines.

Given these issues, there was a need to reexamine the Indian regulations meant to ensure quality control standards and see if they could be made better. There have been multiple calls to strengthen the laws and make things more difficult for errant firms.

The case for stronger laws is important for two reasons. First, the health rights of the Indian citizen need to be accorded the highest priority. People paying for medicines need assurance that the medicines will work as expected — and not harm them.

Second, India has become known as the pharmacy of the world for being able to supply high-quality generics globally after the change in the patent regime in 2005. The government can ill-afford to fritter away that reputation. While the US FDA has stringent quality checks to ensure that the drugs that are supplied by Indian firms to the US are of good quality, for other countries, such as Gambia, Uzbekistan, and Sri Lanka, India’s reputation as a hub of good quality generic manufacturing has been enough till now.

Unfortunately, the amendments to the Drugs and Cosmetics  Act, which governs the quality of Indian drugs, by the Jan Vishwas legislation may have tilted too far in favour of manufacturers, while not considering the implications it may have for consumers.

The D&C Act prescribes separate punishment for non-standard quality (NSQ) drugs, adulterated drugs, and spurious drugs, with the latter two being considered greater evils. NSQ drugs are considered a minor offence. But this is problematic, as drug industry activist Dinesh Thakur, lawyer T Prashant Reddy, veteran pharma journalist Priyanka Pulla and others have pointed out from time to time.

NSQ drugs fail to meet the legally-mandated standards prescribed in the pharmacopoeia. They may not contain enough active ingredients or may fail the dissolution case or on other parameters. At any rate, the medicine will not work as it is intended to.

The regulatory assumption is that NSQ drugs do little harm. It may not cure the patient, but it will not kill him or her. But that is a wrong assumption because an NSQ antibiotic can cause grievous harm to a patient suffering from a life-threatening infection, and an NSQ blood pressure medicine can do long-term harm to a hypertensive patient who takes it regularly.

Section 27 D of the D&C Act earlier prescribed a punishment of a maximum of two years and a minimum of one year (with exceptions for special circumstances), along with a fine of 20,000 for those manufacturing NSQ drugs. It was hardly an adequate punishment. The Jan Vishwas Bill makes the punishment compoundable, allowing pharma company executives to escape prison time by paying a fine of 5 lakh  — a mere slap on the wrist for the errant firm and its executives.

The ease of doing business in India does need to improve,  and it can be done in myriad ways — from ensuring the stability of policies and taxes, including input import duties, to giving incentives to invest in better machinery. It should not come at the cost of patient rights and safety.

The writer is former editor of Business Today and Businessworld, and founder of Prosaic View, an editorial consultancy