Drugs, pharmaceuticals, medical devices made by Indians
This is a collection of articles archived for the excellence of their content. |
Contents |
Cancer detection
2019/ Test to detect spread or relapse
Umesh Isalkar, August 21, 2019: The Times of India
A simple blood test costing Rs 15,000 will soon help doctors detect the spread or relapse of cancer in patients, helping them to plan an efficient treatment module. The test, based on a liquid biopsy technology called OncoDiscover, will help pick up circulating cancer cells in a patient’s blood much before they have affected or spread to other body parts.
Developed by Pune-based scientist Jayant Khandare, the diagnostic tool may also be used to plan treatment or to assess how well the existing treatment regime is working. “The test will be launched in a phased manner all over India from September,” Khandare told TOI.
‘Indian cancer test kit will be far cheaper than the US version’
The long-term plan is to release the test in key global markets within the next few years,” Khandare told TOI. Khandare is the chief scientific officer at Actorius Innovations and Research Pvt Ltd, a startup co-founded by him and Aravindan Vasudevan in 2013. The startup has been funded for high-risk innovation by the Biotechnology Industry Research Assistance Council, an industry support wing of the department of biotechnology, Union ministry of science and technology.
Khandare said the technology was among the few laboratory-to-clinic translational researches, a rarity in India. “OncoDiscover can allow regular monitoring of disease progression. It can also help in providing an early indication for cancer relapse. It is a blood test that detects circulating tumour cells even when their presence is extremely low or minuscule in a patient’s blood,” he said.
The Central Drugs Standard Control Organisation, the regulatory body for drugs and medical devices, has already granted a licence for the manufacture and sale of the test kit in India under the Medical Device Rules, 2017.
Khandare says it is the second such technology in the world, after the one already available in the US. The Indian version would be far cheaper and more specific than the US one, he said. “CellSearch, the US test for the detection of circulating tumour cells has been sold to Menarini Biotech by Johnson & Johnson. It has been available in the US since 2004 and has the approval of the US Food and Drug Administration. The test costs between Rs 84,000 and Rs 1 lakh and is not available in India,” Khandare said.
Trientine/ D-Pencillamine
MSN Laboratories/ 2019
Over two years after patients of a rare genetic condition called Wilson’s Disease suffered due to acute shortage of a life-saving drug called D-Pencillamine across the country, there is finally a reason to cheer. An Indian company has begun manufacturing a drug called Trientine, which is considered superior to D-Pencillamine due to fewer side-effects, at a fraction of its international price.
What makes this new drug launch an emotional event is the behind-the-scenes lobbying by a group of parents, an NGO and a doctor from Mumbai who worked to convince Hyderabad-based MSN Laboratories to take up the manufacture of Trientine.
At a time when stories of the greed of pharmaceutical companies abound, this is a positive instance of pharmaceutical support. Dr Aabha Nagral, a hepatologist who set up NGO Children’s Liver Foundation, said a couple of children had to stop treatment when the drug shortage occurred in 2016.
‘Firm involved in social work; not driven by profits’
We organised a picnic for our patient group where two youngsters shared that they had no drugs at that time and were worried about the future,” said Dr Nagral, who has treated approximately 100 Wilson’s Disease patients in her care at any given time.
The Ranes from Vile Parle, too, recall how their daughter Gauri was hospitalised a few times during the shortage. “Fluid would get accumulated in her abdomen, requiring hospitalisation. It was a traumatising time as her liver was failing quickly,” said Satish Rane. Luckily, she got a cadaveric liver donation and is doing well since the transplant a year ago.
Rajesh S (name changed), a 45-year-old research scientist, was diagnosed with Wilson’s Disease a year back. “We had heard of shortages and expensive medicines costing almost Rs 1 lakh for 100 tablets but we now pay Rs 16,000 for 100 tablets,” said his wife.
The turnaround took months of gathering information and planning. After the shortage was fixed by the Union government’s directive to pharmaceutical companies in August 2016, Dr Nagral and the patient group actively started to seek information about Trientine. They heard from pharmaceutical agents that the active ingredient for Trientine was manufactured in an Indian company and exported to multinational companies located overseas.
“We applied through RTI to the Union ministry of information on the manufacture of Trientine and D-Pencillamine, but got little,” said Dr Nagral. That is when they began to directly appeal to pharmaceutical companies for help. MSN Laboratories, which has been manufacturing active pharmaceutical ingredients for export purposes for years, decided to help out. Ajit Bhadauria of MSN Laboratories said the company didn’t take up the manufacture of Trientine for profits. “It is purely a part of our social work as a pharmaceutical company,” he said.
Vaccines
Pneumonia vaccine/ 2020
Sushmi Dey, India gets its first desi pneumonia vaccine, July 16, 2020: The Times of India
NEW DELHI: India has got its first locally developed pneumonia vaccine, reducing its dependence on imports for immunisation against a disease that contributes to most deaths in children under five years of age. The Drugs Controller General of India (DCGI) on Tuesday approved Pneumococcal Polysaccharide Conjugate Vaccine developed by Serum Institute of India. The Pune-based company can now manufacture the vaccine in India for use.
This vaccine is used for active immunisation against invasive disease and pneumonia caused by “streptococcus pneumonia” in infants. “Having an indigenous pneumococcal vaccine will be a game-changer in our endeavour to reduce child mortality. Pneumonia is the most important cause of child deaths, and pneomococci are responsible for half of serious pneumonias. India’s vaccine is a boon for our country and the world,” says Dr V K Paul, member -health at NITI Aayog.
India accounted for the second highest number of deaths in under-five children in 2018 because of pneumonia. According to Unicef, India reported 1,27,000 under five deaths due to pneumonia in 2018. Earlier, the demand of this vaccine was met substantially by licensed importers in the country since the manufacturers were all vaccine companies based outside. The regulatory approval is based on clinical evidence secured by the company after conducting Phase I, Phase II and Phase III clinical trials of the vaccine. Serum Institute has conducted these trials in India as well as in Gambia.
While immunisation against the disease has improved in India led by government initiatives and awareness programmes, many children — mainly female children — are still left out of the coverage. Experts say a locally made vaccine is likely to make the vaccine more accessible and affordable.
India accounted for the second highest number of deaths in under-five children in 2018 because of pneumonia. According to Unicef, India reported 1,27,000 under five deaths due to pneumonia in 2018.
Covaxin/ 2021
Swati Bharadwaj, January 23, 2021: The Times of India
Amid efficacy row, Covaxin gets thumbs-up from Lancet
HYDERABAD: Amid a raging controversy over the efficacy of Covaxin, India’s first indigenous Covid-19 vaccine, reputed medical journal the Lancet Infectious Diseases said the vaccine produced tolerable safety outcomes and enhanced immune responses in its Phase 1 trials.
With this, Covaxin has become the first Covid-19 vaccine from India to have its data published in Lancet, said Suchitra Ella, joint managing director of Bharat Biotech, which is developing the vaccine in association with the Indian Council for Medical Research and the National Institute of Virology, Pune.
"BBV152 (codename for Covaxin) induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response," said the journal.
Covaxin was well tolerated in all dose groups, with no vaccine-related serious adverse events and the sole serious adverse event was not causally associated with the vaccine, the journal said.
According to biotech industry experts, any vaccine causes some discomfort like pain or fever but it is said to be tolerable when it is resolved without any treatment and is considered safe. A serious adverse side-effect is one which takes a lot of time and effort to treat and causes partial damage to the subject.
The biggest criticism against Covaxin was that none of its data was in the public domain when it was given emergency-use authorisation. Sources said Bharat Biotech is hoping to counter the critics with the Lancet piece.
Terming it as "international validation of Indian innovation", Ella tweeted: "Extremely proud to announce Phase 1 clinical trial studies of Covaxin published in the most prestigious medical journal of The Lancet Infectious Diseases."
Ella also said that 13,000 volunteers (out of 25,800) have been successfully administered the second dose of Covaxin in Phase 3 trials.
Lancet said all adverse events observed in the Phase 1 trials were mild or moderate and were more frequent after the first dose than the second. No significant differences were observed between the vaccinated and control groups, it added.
The most common adverse event was pain at the injection site, followed by headache, fatigue and fever. "The overall incidence of solicited local and systemic adverse events in this study was 14-21% in all vaccine-treated groups, which is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates," it said.
As many as 44 unsolicited adverse events were reported by 24 (6%) of the 375 participants. The healthy volunteers, in the 18-55 years age group that were enrolled in the trials conducted in July-August 2020, were administered the two doses 14 days apart.
Of those enrolled, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only).
Apart from carrying Covaxin Phase 1 trial data, the Lancet carried another article saying that the indigenous Indian vaccine was a "welcome addition to the Covid-19 vaccine landscape". But it also said that it would wait for Phase 3 trial results.
Pointing out that mathematical models indicate there will not be an adequate supply of vaccines available to cover the global population until 2023, the article said: "Bharat Biotech, experienced with developing and distributing vaccines to LMICs (low & middle-income countries) is poised to bridge the vaccine disparity gap using the well-established inactivated whole-virus vaccine platform."
However, it said that until questions about BBV152’s efficacy and ability to subvert a Th2 response are answered by a more diverse multinational Phase 3 trial to comprehensively assess efficacy and long-term safety, "we will wait with cautious optimism on this vaccine candidate poised to bolster worldwide equitable access to Covid-19 prevention".
