From March 2021, pharma firms marketing drugs will be held responsible for their quality

Our Bureau New Delhi | Updated on February 14, 2020 Published on February 14, 2020

Currently, only the manufacturers are held liable under the Drugs and Cosmetics Act

Pharmaceutical companies that market drugs will now fall under the ambit of the Drugs and Cosmetics Act (DCA), according to a notification issued by the Ministry of Health and Family Welfare (MoHFW).

This means they will be held liable if the drug is found to be spurious, or its quality is deemed sub-standard. At present, only the manufacturer of the drug is held liable under the DCA.

Most pharma majors depute third-parties to produce drugs under ‘contract manufacturing’ deals. The pharma firms themselves, which market the drug, would lend the products their brand names, affixing their names on the packages for sale and distribution..

For example, Cipla markets a pack of 10 anti-acidity tablets, Pantosec (pantoprazole 40 mg). The company has deputed Pure & Cure Healthcare, a subsidiary of Haridwar-based Akums Drugs & Pharmaceuticals, to manufacture the drugs.

Regulatory compliances

“Any marketer who sells or distributes any drug shall be responsible for the quality of that drug as well as other regulatory compliances, along with the manufacturer, under these rules,” the latest notification states.

For drugs found to be sub-standard, the penalty involves three to five years of imprisonment. For those found to be spurious, the sentence could include life imprisonment. These clauses will apply to marketing firms too, come March 2021, when the amendments to the DCA take effect.

The Drug Controller General of India, in 2018, had mooted bringing marketing firms under the ambit of the law. Drug inspectors routinely collect samples of drugs from chemists and hospitals to run quality checks and upload the monthly reports of the results in the public domain.

Published on February 14, 2020

A letter from the Editor

Dear Readers,

The coronavirus crisis has changed the world completely in the last few months. All of us have been locked into our homes, economic activity has come to a near standstill. Everyone has been impacted.

Including your favourite business and financial newspaper. Our printing and distribution chains have been severely disrupted across the country, leaving readers without access to newspapers. Newspaper delivery agents have also been unable to service their customers because of multiple restrictions.

In these difficult times, we, at BusinessLine have been working continuously every day so that you are informed about all the developments – whether on the pandemic, on policy responses, or the impact on the world of business and finance. Our team has been working round the clock to keep track of developments so that you – the reader – gets accurate information and actionable insights so that you can protect your jobs, businesses, finances and investments.

We are trying our best to ensure the newspaper reaches your hands every day. We have also ensured that even if your paper is not delivered, you can access BusinessLine in the e-paper format – just as it appears in print. Our website and apps too, are updated every minute, so that you can access the information you want anywhere, anytime.

But all this comes at a heavy cost. As you are aware, the lockdowns have wiped out almost all our entire revenue stream. Sustaining our quality journalism has become extremely challenging. That we have managed so far is thanks to your support. I thank all our subscribers – print and digital – for your support.

I appeal to all or readers to help us navigate these challenging times and help sustain one of the truly independent and credible voices in the world of Indian journalism. Doing so is easy. You can help us enormously simply by subscribing to our digital or e-paper editions. We offer several affordable subscription plans for our website, which includes Portfolio, our investment advisory section that offers rich investment advice from our highly qualified, in-house Research Bureau, the only such team in the Indian newspaper industry.

A little help from you can make a huge difference to the cause of quality journalism!

Support Quality Journalism
This article is closed for comments.
Please Email the Editor
You have read 1 out of 3 free articles for this week. For full access, please subscribe and get unlimited access to all sections.