Indian Pharma News

In a significant development, India’s top drug regulator has given nod to two domestic pharmaceutical companies--Cipla and Hetero for marketing authorization of anti-viral drug Remdesivir only for “restricted emergency use” on Covid-19 patients with moderate disease (those on oxygen), a senior government official told ANI.
With this development, India is soon to begin the domestic production of anti-viral drug remdesivir which would have efficacy, stability, safety for “restricted emergency use” on Covid-19 patients, official added.

New Delhi, Jul 23 : The government has issued notices to pharma firms including Cipla, Dr Reddy's, Biocon, Lupin, Alembic Pharma, and Sanofi India, for introducing drugs without prior approval from the national drug pricing regulator, Parliament was informed on Tuesday. "Companies that introduced a total of 22 drugs "without prior approval of the National Pharmaceutical Pricing Authority (NPPA) have been issued notices," Minister for the Chemicals & Fertilizers, D V Sadananda Gowda said in a written reply in the Lok Sabha.

Read more at Business Medical Dialogues: 22-member Committee Constituted to guide CDSCO on Medical Device Regulation https://business.medicaldialogues.in/22-member-committee-constituted-to-guide-cdsco-on-medical-device-regulation/

In the year 2017-2018, the Indian pharmaceutical industry exported drugs worth USD 17.3 billion. However, despite India’s generic drug manufacturing industry constituting 30 percent of the volume of the global pharma industry, it only forms 10 percent of its value.

India is a leading country in the world’s generic drug market. The Indian pharmaceutical sector supplies over 50 per cent of the global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicines in UK. In the year 2017-2018, the Indian pharmaceutical industry exported drugs worth USD 17.3 billion. However, despite India’s generic drug manufacturing industry constituting 30 percent of the volume of the global pharma industry, it only forms 10 percent of its value. This means that the pharma sector will have to do more than just manufacturing copies.

US: Concluding that Victoza (liraglutide) injection has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes, the U.S. Food and Drug Administration (FDA) has given its nod to the Novo Nordisk’s drug to treat patients aged 10 years and above.

A class of drugs is emerging that can attack cancer cells in the body without damaging surrounding healthy ones. They have the potential to replace chemotherapy and its disruptive side effects, reshaping the future of cancer care. The complex biological medicines, called antibody drug conjugates (ADCs), have been in development for decades, and are now generating renewed excitement because of the success of one ADC in late-stage testing, a breast cancer treatment called DS-8201.

Pfizer’s troubled JAK inhibitor Xeljanz has had its share of hiccups after pulmonary embolism fears derailed the drug’s higher dose in rheumatoid arthritis. Now, Pfizer is hoping for better results using Xeljanz to treat RA patients who wean off immunosuppressants.

NEW DELHI: Around 40% of the essential medicines in India with lowest MRP are priced significantly higher than estimated production costs, an assessment by the World Health Organisation (WHO) shows highlighting the “exorbitant” profiteering by pharmaceutical companies and the scope for lowering prices of drugs.

While innovative and newer drugs for cancer, hepatitis C and rare diseases are out of reach of many due to their unaffordable prices, even off patent drugs which are in market for long and commonly used for diseases like HIV, tuberculosis and malaria are priced very high with huge margins over their cost of production.

As per Indian Council of Medical Research data, India will have over 17.3 lakh cancer cases by 2020 -- a doubling of cases in 25 years. It may see over 8.8 lakh deaths due to the disease, with only 12.5 per cent of the patients receiving treatment in early stages.
With cancer being India’s second biggest killer after heart disease, the nation is staring at a cancer crisis, with unequipped hospitals, spiralling cost of treatment, belated diagnosis and the doctor-patient ratio gap all causing large-scale problems. However, to lessen the deficit of tertiary cancer care in the country, India’s biggest cancer hospital is coming up at Haryana’s Jhajjar, which will have over 700 beds exclusively for cancer patients.

Companies developing orphan drugs will soon get a boost from Indian drug regulator through partial and full waiver of clinical trials depending on specific drugs, said Chandrashekar Ranga, Deputy Director General of Central Drugs Standard Control Organization (CDSCO)

The government is expected to come out with a clear policy on approvals of orphan drugs in the New Drugs and Clinical trials Rules, 2018, which will be notified in coming weeks.

India's National Pharmaceutical Pricing Authority (NPPA) has capped the prices of 42 medicines that are used to treat different types of cancers. The formulations whose retail prices have been fixed include Trastuzumab injection indicated for treatment of metastatic breast cancer and gastric cancer. The regulator has also fixed the prices for Metformin plus Gliclazide tablets used for treatment of type 2 diabetes, among others.

NEW DELHI: The drug price regulator National Pharmaceutical Pricing Authority is expected to cap trade margins of 73 medicines for cancer and rare diseases, expanding the span of price control to curtail profiteering on various which are currently outside the purview of government regulation. A decision in this regard is likely to be taken on Thursday in the authority meeting of the regulator.

However, the move has triggered concerns because the list has left out commonly used medicines with higher market turnovers, entailing a potential risk of prescription substitution, sources said.

The Union health ministry has relaxed regulations to facilitate speedy availability of unapproved drugs, medications which are not permitted to be imported or marketed in the country, in small quantities for personal use. The decision is expected to bring some relief for patients who are in dire need of such imported life-saving medicines. The ministry, after consultations with the Drugs Technical Advisory Board, has amended the Drugs and Cosmetics (D&C) Rules of 1945 to this effect and the new regulation came into force on June 1.

In a proposal submitted to the Prime Minister’s Office, the Niti Aayog suggested tweaking the current price fixation mechanism “to check exorbitant prices” of essential medicines. Market and institutional data such as costs at central, state and private hospitals will be used to arrive at ceiling prices.

NEW DELHI: The government is considering a proposal to make essential medicines more affordable by capping prices at the first ‘point of sale’ rather than retail price — a move intended to curb margins offered to hospitals, distributors and doctors to push particular brands.

Chennai: The Central government has approved proposals for setting up of 15 state cancer institutes and 20 tertiary care cancer centres across the country, Prime Minister Narendra Modi said on Thursday.

Chennai: The Central government has approved proposals for setting up of 15 state cancer institutes and 20 tertiary care cancer centres across the country, Prime Minister Narendra Modi said on Thursday.

New Delhi: Trade margins charged by drug stockists and chemists must be capped, government think tank NITI Aayog recommended, a move that promises to bring down drug prices while trimming industry profits.

The recommendation, if accepted, will bring down the prices of scheduled drugs which are under price control, and non-scheduled drugs which are not. Trade margin is what wholesalers and retailers earn by selling the medicines.

Natco Pharma has launched a generic version of pomalidomide capsules, used in the treatment of a type of blood cancer, in India. “Pomalidomide is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy,” Natco said in a BSE filing today.

Zurich: Roche (ROG.S) said on Tuesday a late-stage study showed the Swiss drugmaker’s immunotherapy Tecentriq plus chemotherapy cut the risk of disease worsening or death in first-line treatment of people with a type of advanced lung cancer.

“Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades,” said Sandra Horning, Roche’s chief medical officer, adding the company was still awaiting overall survival data in its Impower131 study.

MUMBAI: An eleven-year-long trial by the Tata Memorial Hospital (TMH) has established that women with advanced cervical cancer should not be treated with surgery, which is widely offered the world over. Instead, a combination of chemotherapy and radiotherapy increases five-year survival chances. The findings assume significance in India, where 60 per cent of cervical cancer cases are detected at an advanced stage. The trial highlights the need for India to vastly increase radiotherapy centres from the meagre 530 that exist today, that too mostly in metro cities.

NEW DELHI: Doctors at AIIMS have introduced a new technology for treating cancers affecting the abdominal lining, for example colon cancer or colorectal cancer. It involves administering heated chemotherapy drugs directly into the abdomen during surgery.

Usually, chemotherapy drugs are infused into the veins post-surgery to destroy cancer cells. With the new technology, doctors said they were able to deliver higher dosage of chemotherapy drugs.

Domestic pharma companies received more than 300 approvals in 2017 to launch generic drugs in the US, which is an all-time high. The clearances came despite regulatory pressure from the US Food and Drug Administration (FDA), and unprecedented warning letters issued to the pharma companies' facilities. The final approvals for Indian players are up by nearly 43% from 211 in 2016, and corner about 40% of all global filings in the highly lucrative around $70-billion US market. This, even as all drug biggies — including Zydus, Sun Pharma, Dr Reddy's and Cipla — faced regulatory ire, while some were pulled up for manufacturing lapses by the US regulator during last year.

A walk through the corridors of Tata Memorial Hospital in Parel would help understand India's diversity. Patients from across the country can be found waiting outside the outpatient departments and wards. But there is a flip side to this overcrowding: Long queues for consultation, radiation and surgery. For patients, it means they have to leave their homes and income for six months or more to stay in Mumbai.

The hospital, which functions under the department of atomic energy, has been working on various initiatives to "decentralize" cancer therapy. From offering online consultations to education modules, the hospital is trying to popularize uniform treatment plans so that patients don't have to travel to Parel. "We have started offering medical education modules online. Also, doctors don't have to leave their practice to pick up new skills," said Tata Memorial Hospital's professor Dr Pankaj Chaturvedi. Some of the initiatives:

The cancer drug that treated former US president Jimmy Carter who was suffering from melanoma, a deadly form of skin cancer, might be hitting the Indian market by September 2016. Carter was being treated with a cancer drug called Keytruda that uses the immune system to fight off cancerous cells.

Various medical experts said the drug which has been approved by the US Food and Drug Administration (FDA) will increase the curability rate by 20 per cent and prolong the life of the cancer patients. Currently, the hospitals are importing the drug from foreign country. Another drug, Opdivo, will also be made available at the same time. Opdivo is also used to treat melanoma.

Oncologist Radheshyam Naik works at HealthCare Global (HCG), a Bangalore-based hospital chain that specialises in caring for patients with cancer, and sees about 150 cancer patients a month. About one-tenth of his patients have ailments for which drugs exist but are not available in India. Among them is a 45-year-old software professional who has a kind of bone marrow cancer. The patient, who does not want to be identified, may at best be able to pull along for another six to nine months on drugs currently available. The father of two school-going children, he is being treated with thalidomide. "He needs pomalidomide but it is not available in India," says Naik.

The new drug is life-extending, rather than life-saving, but even that can make a big difference. "This drug would make things better for him for at least the next two years, by which time there may be another drug available that could either extend his life further or offer a new solution," says Naik.

Cancer drugs, being the top focus for research and development, corner the lion's share of medicines launched globally, yet only a handful make it to developing countries like India. Only seven oncology drugs were introduced in India over five years (2010-2014), when nearly 50 breakthrough therapies were rolled out globally.

The disparity in availability of oncology therapies becomes even more stark over a 10-year period (2006-2016), with not even one-third of the 270-odd onco-molecules being available in India, a country with over 10 million cancer patients, data culled by TOI from QuintilesIMS, a technology-driven healthcare service provider shows.