Despite Winning In Court, Patna Teen Will Have To Wait Longer To Get New TB Drug

The teenager's father will have to first make an application before the Drug Controller General of India to import the drug from the manufacturer.

New Delhi: A Patna teenager, who is suffering from extremely drug-resistant tuberculosis, has won her right to a necessary drug in court. But it would be at least another 16 days before she has it in her hand. The delay will be due to the lengthy administrative process, which her father Kaushal Kishore Tripathi is dealing with.

The teenager who has been suffering from extremely drug resistant TB for the last six years, needs the drug ‘Bedaquiline’, as she has failed to respond to traditional antibiotic drugs. But under the Conditional Access Programme, Bedaquiline was made available only in six centres in India. It was not available in Bihar, where the teenager lives.

Her parents appealed to the courts for their daughter’s treatment and the drug be made available for her in Patna. Last week, the Delhi High court allowed access to the new anti-TB drug – Bedaquiline to teenager’s doctor Zarir Udwadia.

The court said she will be administered Bedaquiline by Hinduja Hospital, Mumbai, under the supervision of her personal doctor Zarir Udwadia while the government will make bedaquiline available through KEM Hospital in Parel which is one of the six sites where the drug is administered.

Mr Tripathi said, “My daughter is in a lot of pain and very weak now, so we will go to Mumbai when the paperwork is sorted and she can be given the medicine.”

The paperwork

Mr Tripathi will have to first make an application before the Drug Controller General of India (DCGI) to import the drug from the manufacturer Janssen Pharmaceuticals on compassionate use basis. The court has asked that DCGI to clear the application within 24 hours.

After Janssen Pharma gives its approval, that approval along with DGCI clearance will have to be produced ahead of the Central TB Division that will then make the drug regime available through KEM hospital to Dr Udwadia.

Since Bedaquiline is a highly-restricted drug, once Janssen Pharma sends Bedaquiline to Dr Udwadia, he will give it to KEM Hospital for replenishment of its stock.

Dr Zarir Udwadia, confident that the drug can make a positive difference, told NDTV, “I have not encountered any significant side effects in the 30 Indian patients that have been administered Bedaquiline. Of course, it must be responsibly used and given with careful cardiac monitoring.”

What Other Experts Are Saying

Though international experts have been advocating for the 18-year-old, they also have a caveat.

Riitta Dlodlo, Director of TB Programe at The Union said that merely providing access to a drug is insufficient. Ms Dlodlo said that even the drug susceptible TB has to be treated by combination therapy that requires more than one medicine.

“TB programe run by India is very strong and it is a wise decision to retain the new drugs that can be used for drug resistant TB. Government can control so that the medicine is accessed by the right person because not every drug resistant TB patient requires Bedaquiline,” she added.

Is Bedaquiline enough? Experts say, strike the right balance

Ms Dlodlo said that early diagnosis using rapid molecular tests, prompt effective treatment based on drug susceptibility profile followed by control measures. It is a challenge for National TB Programmes to strike a balance between ensuring individual patient rights and retaining the potency of new TB drugs for years to come.

She emphasized the need for health systems to prevent the rise of drug resistant TB and when it occurs that it should do everything in its power to provide access.

“Patient treatment must be guided by the drug susceptibility profile. It is essential that drug-sensitivity testing be performed at the outset, so that healthcare workers know which medicines are likely to be effective in treatment and which will be ineffective due to resistance,” Ms Dlodlo added.

According to the experts, the TB menace in India can be controlled by deciding the best treatment for a patient using the rapid molecular testing methods. This will also be useful in preventing the TB condition from spreading to the family members and health workers.