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 The continued manufacture and sale of Ranitidine, the acid reflux treatment drug, in India must stop; government inaction is jeopardising Indian lives

GSK and 2.2 billion dollars settlement

Last month, the multinational pharmaceutical company, GSK announced a record settlement of $2.2 billion in the United States .

to settle multiple lawsuits regarding one of its best selling drugs to treat “acid reflux”– Zantac ®, containing the active ingredient Ranitidine, after it was revealed that the drug contained high amounts of a cancer causing carcinogen called N-nitrosodimethylamine (NDMA).

Valisure, the American pharmacy 

which first raised the issue, testing of various brands of Ranitidine in its labs found NDMA in excess of 3,000,000 nanograms in some samples; the acceptable limit in the U.S. was 96 nanograms. Like all carcinogens, high exposure to NDMA can cause cancer.

stability issues with the molecule

The high amounts of NDMA have been attributed to stability issues with the molecule, which means that it is not a GSK-specific problem. 

कौन सी एजेंसी की तरफ़ से कदम उठाया गया है ??

 United States Food and Drug Administration (USFDA) and the European Medical Agency (EMA) stopped the sale of the various brands of Ranitidine in their jurisdictions as far back as 2020. 

GSK क्या भारत में भी व्यापार कर रही है ??

GSK itself informed stock exchanges in India, in 2020, that it was withdrawing all Ranitidine products in India. 

Characteristically, India’s Ministry of Health has taken no steps to stop other pharmaceutical companies from continuing to manufacture and sell Ranitidine.

A widely used pharma drug

भारत में कब मामला सामने आया ?

Back in 2021, after reports in the Indian press pointed out how Ranitidine was still being sold in India, 

there were some murmurs from the government indicating that it was “looking into” the issue; but there has been no action from the government since then.

There are two questions to for government 

The first is, why did the Indian regulatory never detect/respond to similar levels of impurities in Ranitidine, which is widely consumed in India. 

The second, why has the government not acted over the last five years in a similar vein as its counterparts in the West to stop the sale of Ranitidine in India, 

especially when there are enough substitutes in the form of other drugs such as 

• famotidine, 
• cimetidine, 
• esomeprazole, 
• lansoprazole or omeprazole which also treat “gastroesophageal reflux”, the medical phrase for “acidity”.

To answer these questions : 

it is first important to identify the key institutions within government responsible for different stages of regulating generic drugs.

The chain of standards setting

About Indian Pharmacopeia Commission (IPC)

The task of setting standards, including acceptable limits of impurities and analytical methods for testing generic drugs for such impurities lies with the Indian Pharmacopeia Commission (IPC), an autonomous institution under the Ministry of Health and chaired by the Secretary of Health. 

In addition to publishing the Indian Pharmacopeia, which lays out standards (including limits for impurities) and testing protocols for different drugs, the IPC is also required to manufacture and supply “reference standards” and “impurity standards” against which drugs such as Ranitidine can be tested in quality control laboratories in the public and private sector.

आईपीसी ने जो बोला है वह कैसे पूरा होगा ?

first

with the State drug controllers responsible for issuing manufacturing licences for such drugs and, 

second

with drug inspectors of the States and the Centre who randomly draw samples of drugs from the market for testing by analysts in government laboratories against the standards laid down by the IPC. 

Drugs that fail to comply with the IPC’s standards are deemed to be “not of standard quality”.

अब प्रश्न उठता है आईपीसी से - आपने अभी तक कोई इश्यू क्यों नहीं खोज लिया ?

With this background, the key questions to ask of the IPC are why did it not detect the NDMA issue with Ranitidine and what exactly has it done since 2020 to lay down permissible standards for NDMA in Ranitidine, along with the testing protocols. 

We cannot answer these questions 

because we have no access to copies of the latest version of the Indian Pharmacopeia. 

It costs ₹50,000 to purchase the most recent version of theIndian Pharmacopeia. 

Ideally it should be made available for free given that it contains binding legal standards and is very important from a public health perspective. 

Once the IPC sets the permissible limits for NDMA in Ranitidine

ideally, the manufacturers of Ranitidine who cannot comply with the impurity standards laid down by the IPC either stop manufacturing Ranitidine 

or drug inspectors prosecute these manufacturers for manufacturing “not of standard quality” drugs.

किस सरकार को जिम्मेदार ठहराया जाएगा ??

Separate and apart from the role of the IPC in setting standards, there is the question of who in government is responsible for acting to prohibit a drug from being sold in the market once a public health concern has been flagged anywhere in the world. 

Under Section 26A of The Drugs and Cosmetics Act, 1940 only the central government, or more precisely, the Drug Regulation Section within the Ministry of Health has the power to prohibit the manufacture and sale of drugs in the country. 

This section in the Ministry lacks the technical competence to perform its job since it is typically headed by a faceless Joint Secretary from the civil services who knows little about the pharmaceutical industry or pharmacology.

Perhaps it is now time, after a $2.2 billion settlement, for the Ministry of Health to swing into action and issue an order under Section 26A prohibiting with immediate effect, the continued manufacture and sale of Ranitidine in the country.

Source the hindu