Updated USPSTF recommendations on BRCA1/2 testing in women

• For women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or an ancestry associated with BRCA1/2 gene mutation, the US Preventive Services Task Force (USPSTF) recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 (BRCA1/2) gene mutations with an appropriate brief familial risk assessment tool.

Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing (Grade B).

• For women whose personal or family history or ancestry is not associated with potential harmful BRCA1/2gene mutations, the USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations (Grade D).

Healthcare News Monitor

Ayushman Bharat emerges as core of development agenda

ET Healthworld-PTI

Puducherry: Health sector has finally but effectively emerged as the core of the countrys development agenda with Ayushman Bharat, said member of on Sunday. Addressing graduates of different disciplines at the annual convocation of centrally sponsored JIPMER after presenting awards to them, Paul said Ayushman Bharat represented a comprehensive healthcare vision and was an effort and initiative taken never before. A number of health and wellness centres was being set up to strengthen the primary healthcare service under Ayushman Bharat, he said. Expressing concern over shortage of specialists in the health sector, Paul said shortage of specialists was so profound that one shudders at the scenario. Although every year around 6.5 crore surgeries need to be done only 2.5 crore was being done now. The shortage of human resources is thus a challenge, he said. Also, Paul called upon the medical professionals to ensure that the trust and faith society had in them was not lost. "We are revered by the society which is a legacy and treasure for us," he said while asking institutes to nurture excellence and values. "Excellence and values go hand in hand in medical profession. Professionalism without humanism is incomplete," he said. Medical graduates should don the role as academics and contribute as teachers, researchers and public health exponents or expertise, Paul said.

Clinical pharmacists to give booster dose to healthcare

Telangana Today- M. Sai Gopal

A separate cadre of clinical pharmacists with clearly defined job responsibilities and exclusive Drug Information Centres in hospitals, one of the vital layers in the healthcare system that has been lacking for a long time, could be a reality in the coming months. In the Central Council meeting of Pharmacy Council of India (PCI) held this month, the council approved to amend Pharmacy Practice Regulations (PPR), 2015, and include provisions to create posts for Clinical Pharmacists with clearly defined criteria of qualifications, duties and responsibilities. It has also decided to include in the PPR the need to create Drug Information Centres across hospitals in the country. The changes to these regulations by the PCI, which is a statutory body working under the Ministry of Health and Family Welfare (MOHFW) to regulate the profession of pharmacy, is bound to have a positive impact in States. With due approval from the Ministry, the PCI had in 2015 notified Pharmacy Practice Regulations, which had a clear definition of ‘Clinical Pharmacist’ as pharmacy practitioners. However, it did not define the job responsibilities of a clinical pharmacist, the need to create posts or separate cadre and the setting up of Drug Information Centres in hospitals.

The dangerous cocktail of substandard drugs and poor regulatory oversight in India

moneycontrol - Viswanath Pilla

Last week, the Health Ministry suspended an official of India’s drug regulatory body the Central Drugs Standard Control Organisation (CDSCO) after he was arrested by the Central Bureau of Investigation (CBI) on charges of corruption. According to a statement by Health Ministry -- Dr. Naresh Sharma, Deputy Drug Controller (I) at CDSCO headquarters in New Delhi has been "trapped" and was taken in custody by the CBI on August 16 for investigation. "All stakeholders, public and officers shall take cognizance of the fact that CDSCO has the policy of zero tolerance towards corruption and is committed to act stringently against any act of corruption," the Healthy Ministry said in a statement. There were no details of the specific corruption charges. Sharma joined CDSCO in November 2006 after over five years in Dabur Research Foundation. He also previously worked in research and development departments at Cadila Pharmaceuticals, JK Drugs and Pharmaceuticals and Paam Pharma. But his arrest coincides with CBI unearthing a major corruption racket where it booked a CDSCO inspector based in Himachal Pradesh. He was allegedly took a bribe, to approve a substandard drug. CBI sleuths have found samples of dobutamine injection made by Amritsar-based Kwality Pharmaceuticals by the firm, which had failed CDSCO trial. But, the drug inspector agreed to approve the samples, in connivance with officers at the Delhi headquarters in exchange for Rs 1 lakh bribe.

Price cap to take a toll on quality of premium hygiene products

The Economic Times - Sagar Malviya, Ratna Bhushan

Hygiene product makers said they will have to stop pushing premium value-added products and innovations within segments such as sanitary napkins, hand washes, disinfectants and adult diapers if the government puts a cap on their prices. A list of essential hygiene products is reportedly being finalised and these categories could come under price control. Companies say premium items that are costly to manufacture compared with basic versions are still being sold at lower margins unlike pharmaceutical companies that use similar technology and raw materials but have different pricing. Therefore, the analogy doesn’t hold for hygiene products, they argue. “For advertising spends, new launches and even innovation, we need profitability,” said a senior executive at a multinational consumer goods company. “The margin for us and trade is not very high since they are nascent categories and we are focussing on increasing usage by squeezing margins already. Also, it is still not clear whether all price points will be covered.” Companies say using cheaper raw materials to maintain pricing will translate into lower quality products. In India, the sanitary napkin segment is controlled largely by three firms — Procter & Gamble, Unicharm and Johnson & Johnson. RB, which owns Dettol, has a significant chunk of the hygiene and liquid antiseptic market.

Drug regulator preparing list of dual-use APIs imported from unregistered firms

Mint - PTI

The central drug regulator is preparing a list of active pharmaceutical ingredients (APIs), the chemicals used for making medicines that have dual-use and are being frequently imported from unregistered firms, to stop their misuse and improve quality, officials said. "Dual-use APIs, which are being imported from unregistered companies, are comparatively cheaper and of low-quality," a senior government official said. Dual-use APIs are the ones that can be used in making special food products such as nutraceuticals apart from medicines. "The Central Drugs Standard Control Organisation (CDSCO), the Ministry of Health and the Department of Pharmaceuticals want to put a stop to the misuse of such dual-use APIs that are being frequently imported from unregistered sources," said another senior government official. Once the list of such APIs are prepared, it will be submitted to the Department of Pharmaceuticals, he said. The CDSCO is strictly monitoring the import of such dual-use APIs for the last few months so as to get an idea on what kind of action should be taken, he added.