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Govt amends D&C Rules to ease regulation to import unapproved life-saving drugs in small quantities for personal use

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.

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Govt plans to cap drug prices at first point of sale

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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.

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Centre gives nod to 15 state cancer institutes

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.

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NITI Aayog backs cap on pharma trade margins

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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.

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Natco Pharma launches generic blood cancer drug in India

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.

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Tecentriq, chemo cut risk of death in type of lung cancer: Roche

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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.

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‘Advanced cervical cancer needs chemo-radiotherapy, not surgery’

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.

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AIIMS develops new drug delivery system for cancer

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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.

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Indian pharma cos get record 300 USFDA generic drug nods in 2017

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.

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Decentralizing cancer therapy to benefit outstation patients.

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:

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Two new cancer drugs to make their way into India.

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.

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Some new cancer drugs are available in other countries, but not in India.

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.

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India got only 7 of 50 global cancer drugs in 5 years

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.

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