‘Miracle drug’ for TB will be available in India soon

Bedaquiline, the “miracle drug” for the rising drug-resistant population in India, will soon be available as part of treatment for patients suffering from multi-drug-resistant (MDR) and extensively-drug-resistant (XDR) tuberculosis (TB). Union health minister J.P. Nadda will launch the drug ahead of World TB day on March 21. Bedaquiline is the first new TB drug to be approved by the US Federal drug Administration in over 50 years.

To begin with, the drug will be launched in Delhi, Mumbai, Chennai, Guwahati and Ahmedabad and will eventually be introduced all over the country for the patients who are found to be resistant to two vital primary drugs in the DOTS Plus regimen.

As per government records, nearly two million Indians develop TB each year. Mumbai is emerging as ground zero for MDR TB. The launch of the new drug, officials say, is likely to help over 600 patients.

Approved by the US regulator, bedaquiline is used for treatment of MDR TB as part of combination therapy for adults.

Earlier, results from randomised trials on the efficacy of bedaquiline, which was published in the Lancet, showed “significant reduction” in the infection period. Approval of the drug was also based on studies that showed it killed bacteria more quickly than a control group taking the standard regimen. FDA approval for a new TB drug discovered by scientists at Janssen, the pharmaceutical unit of Johnson & Johnson, comes after more than 50 years. Significantly, the drug also got a push from the World Health Organisation (WHO) which advised the inclusion of bedaquiline in the combination therapy for MDR TB in accordance with its existing guidelines.

While eradication of TB continues to be a major health challenge for India, based on the encouraging results on the efficacy of the drug the Indian Council of Medical Research and Central TB Division of DGHS recently convened an expert group for the introduction of bedaquiline in India. “It is proposed to introduce the drug in India under controlled conditions at 6 DOTS plus sites to assess its impact on multi-drug- and extensively-drug-resistant TB.”

Twenty-two countries, including South Africa, bear 80 per cent of the burden of TB worldwide.

According to WHO, there are around nine million new TB cases detected and close to two million people die of the disease yearly.

In India, TB is rated as a major public health problem and the country accounts for one-fifth of the global total.

It is estimated that annually around 3,30,000 Indians died of TB and emergence of MDR TB in recent years. In India, 12 EDR TB cases were detected at Mumbai’s Hinduja Hospital a few years ago.

Health ministry officials say the discovery of bedaquiline may provide new hope to patients suffering from the deadly disease.

344 banned drugs may be diverted The 344 drugs that have been banned in India are likely to be diverted to African countries, or even Saarc countries expect Pakistan and Afghanistan, as the Central government has not banned their exports.

A source in the drug control department said, “The products are not to be consumed in India, but if the importing country has no objections then the drug controllers cannot stop it.”

Drug controllers say that they don’t have a say in what the manufacturers do with the recalled drugs. While the makers of cough syrups Corex and Phensedyl have approached the court and got a stay order, the others are still contemplating legal action. The problem is that this time the government has listed each combination and banned them instead of issuing a bulk order. This means that each pharma company will have to separately go to court for each combination.

Meanwhile, the government gazette gives minimum information about the reason for the ban. A senior pharma official on condition of anonymity said, “These combination drugs have gone through proper regulatory approvals. They have been in the market for a long time. Even the new combinations are approved and only then released in the market. How come they have become ineffective now ”

The central government has been asked to submit the details for ineffectiveness of Corex and Phensedyl to the court as the report is not in public domain.

A senior officer said, “There is very little information in public domain except that it is not viable for human consumption. The expert committee was set up in 2014 and the task was to classify the drugs into rational, irrational and those that needed further studies. Based on the responses and assessment of the products, the drugs have been banned.”

But a case to point is the combination of metformin + gliclazide + pioglitazine, which is used by diabetic patients and which was approved by the Drug Controller General of India. But the combination is now in the list of banned drugs. A senior doctor said, “This drug is very useful for diabetics. The government had approved it earlier, how can it be banned now There are 80 combinations of pioglitazine which are effective for diabetic patients and their ban is going to affect the patients.”

The World Health Organization had approved only 350 formulations of fixed dose combinations to treat prevalent diseases but the pharma companies got too ambitious and made more than 6,000 combinations.

Dr Hari Krishna, a senior physician said, “With 50 per cent of the market containing FDCs it had become a concern for prescribing medicines. For example if a person came with headache and high fever, the combination drugs prescribed mostly were medicines for headache, fever, body pain and cold. For the other two symptoms that did not exist (body pain and cold), the medicine was not required and it caused side-effects.” List of top 10 banned drugs: 1) Corex – stay order from the court 2) Vicks Action 500 3) Phensedyl – stay order from the court 4) Sinarest 5) Tripride 6) Zimnic AZ brand 7) Cheston Cold 8) Euglim 9) Glizonem 10) Gliterais