Patient Safety Capsules
Quality certificates by other entities for medical devices not replacement for license: Clarifies CDSCO
New Delhi, July 13, 2022 : With all non-notified medical devices of Class A and Class B categories scheduled to enter licensing regime with effect from October 1, 2022, the drug regulator has said that the quality certificates issued by other entities shall not be a replacement of license to be granted by the competent licensing authority.
Cyber security critical for healthcare digitalization strategy
Bengaluru, July 11, 2022: Cyber security is vital for healthcare digitalization strategy. There is a need to implement a comprehensive data security strategy that starts with embedding data security principles into the governance frameworks and enforcing risk-based decision-making, said Sourav Chanda, executive director – cybersecurity, Providence India.
Drug Laws & Policy Injections
Ministry of Ayush notifies Pharmacopoeia Committee and sub-committees under PCIM&HNew Delhi, July 12, 2022: The Union Ministry of Ayush has constituted a Pharmacopoeia Committee (PC) and four sub-committees under the Committee to support the functioning of the Scientific Advisory Board (SAB) of the Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H).
DoP modifies guidelines for SPI scheme after deliberations with the industry New Delhi, July 13, 2022: The Department of Pharmaceuticals (DoP) has modified its guidelines for the scheme Strengthening of Pharmaceutical Industry (SPI) to allow an extended 30 month period for the beneficiaries of some of its schemes to complete technological upgradation from the date of first disbursement of loans.
Centre releases draft New Drugs, Medical Devices and Cosmetics Bill, 2022New Delhi, July 11, 2022 : The Union ministry of health and family welfare (MoHFW) has released the draft of New Drugs, Medical Devices and Cosmetics Bill, 2022, a comprehensive legislation with provisions to regulate medical devices, clinical trials and online pharmacy, among others in order to keep pace with changing needs, times, and technology as against the pre-independence legislation of the Drugs and Cosmetics Act, 1940.
PCI warns pharmacy institutions of criminal cases for submitting wrong information or documentsNew Delhi, July 15, 2022: The Pharmacy Council of India (PCI) has warned the pharmacy institutions that it can file criminal cases against the management of the institutions which submit wrong information or fraudulent documents to the Council.
Drug regulator approves country's first indigenously developed HPV by Serum InstituteJuly 11, 2022: India's drug regulator on Tuesday approved the country's first indigenously developed Human Papillomavirus Vaccine (HPV) by the Serum Institute of India (SII).
Government proposes compensation for trial injuriesJuly 11, 2022: Pharmaceutical firms will be liable to pay compensation for injuries and damage caused to participants during a clinical trial, according to the new draft Drugs, Medical Devices, and Cosmetics Bill, 2022.
Pharma Injections
Indian pharma MSMEs can play vital role in international market: Daara PatelChennai, July 15, 2022: The Micro, Small and Medium Pharma Enterprises in India need to be capable enough to compete well in the international markets as chances are there for them to become international sellers.
Pharma industry sees US FDA guidance on patient-focused drug development to bolster faster treatment accessBengaluru, July 13, 2022: Pharma industry sees considerable relevance to the recent US FDA draft norms on patient-focused drug develop-ment: selecting, developing, or modifying fit-for purpose clinical outcome assessments.
CDCO releases draft guidance documents on IVD Medical Devices to help transition to license regime New Delhi, July 14, 2022: As part of its efforts to bring all the medical devices under the licensing regime by next year, the Central Drugs Standard Control Organisation (CDSCO) has released draft guidance documents on stability studies, post-market surveillance, performance evaluation and external evaluation of In Vitro Diagnostics Medical Devices (IVDMD) in the country.
Pharmac South 2022 gathers business worth crores of rupees Chennai, July 11, 2022: The south India's high-powered pharmaceutical and neutraceutical trade expo, Pharmac South 2022, that concluded on July 9 at Chennai Trade Center gathered business worth crores of rupees, according to TN IDMA which organized the event along with Orbit Exhibitions India Ltd, Mumbai.
Generic drug companies in no hurry to launch new Covid products July 13, 2022: After taking progressive measures in the last two years, Indian generic drugmakers are going slow in investing further on Covid-related products as the momentum begins to shift to other therapies, some pharmaceutical industry executives told ET.
Indian pharma can't afford to miss governance bus amid growth focus July 12, 2022: ET Intelligence Group: The emergence of India as a key growth driver for pharma companies is coinciding with an increase in regulatory scrutiny at home.
Drug Dopes
India sees rise in demand for plastic surgery through medical tourism driven by cost and technology adoptionBengaluru, July 15, 2022 : India sees a visible rise in demand for plastic surgery through medical tourism. This is driven by the qualified pool of medical expertise in plastic, cosmetic and reconstructive surgery. Another key factor is the adoption of advanced technology on par with the best in the world. 
Pandemic spurs growth of drug industry’s R&D spendingMumbai, July 13, 2022 : Covid-19 pandemic has prompted Indian drug manufacturers to raise their research and development spending significantly. This will allow for the quick discovery and creation of new drugs that will benefit people worldwide.
Medical Devices industry disappointed on not getting a separate Act New Delhi, July 12, 2022 : The medical devices industry has expressed its disappointment in the government not addressing its aspirations for a separate Act for the sector, while considering the new draft bill for the pharmaceutical and medical devices in the country.
Medicos hail govt’s decision to reduce gap between second & booster doses of Covid-19 vaccine Mumbai, July 12, 2022: Medical professionals have welcomed the Union health and family welfare ministry’s decision to reduce the gap between the second dose and precaution third dose of the Covid-19 vaccine from nine months to six months, saying that it will improve vaccines’ effectiveness against hospitalization and death from severe Covid-19 disease.
Generics of MSD diabetes pill set to flood market as patent expires PTI, June 07, 2022: The oral anti-diabetes drug market is in for a major shake-up as Merck, Sharp & Dohme's (MSD's) Januvia is ex-pected to go off patent this month.
Income Tax Department raids Dolo-650 manufacturer Micro Lab office in BengaluruJuly 6, 2022: The Income Tax Department conducted raids on the office of popular drug Dolo-650 manufacturer Micro Labs Limited located in Bengaluru on Wednesday.
National Injections
Karnataka looks to balance pharmacy education with pharma industry demand to implement ER 2020 Bengaluru, July 14, 2022 : Karnataka looks to balance pharmacy education growth with pharma industry demand to implement Education Regulation (ER) 2020. In order to realise the creation of industry ready workforce, the state government’s drugs control department and the Board of Examining Authority endorsed that the way forward would be collaboration between pharma companies and pharmacy colleges for the successful implementation of ER 2020.
Supreme Court disposes of Cadila Healthcare’s dispute with Gujarat Tax Department on KadiprolNew Delhi, July 14, 2022 : The Supreme Court of India has closed the proceedings of a long-pending dispute between the Gujarat sales tax office and drug major Cadila Healthcare on whether the latter’s product Kadiprol should be assessed as a poultry feed or a medicine, while keeping the larger question on the Common Parlance Test open.
Exporters awaiting more clarity on implementation of RBI’s circular facilitating exim trade settlement in rupees Mumbai, July 14, 2022: Indian drug exporters are waiting for more clarity on the Reserve Bank of India (RBI)’s decision to allow trade settle-ments between India and other countries in rupees.
CDSCO’s south zonal office in Chennai soon to be shifted to its own building at Periyamedu Chennai, July 13, 2022: The Central Drugs Standard Control Organization’s (CDSCO) south zonal office, which has been working in the Shastri Bhavan at Nungabakkam in Chennai, will soon shift to a new building at Periyamedu in the city, constructed by the Union health ministry.
DCGI approves indigenous mRNA Covid jab for emergency use in 18 yrs & above Bengaluru, June 29, 2022: India’s drug regulator on Tuesday approved India's first home-grown mRNA Covid-19 vaccine by Gennova Biopharma for emergency use in 18 years and above.
Pharma businesses with strong quality compliance to emerge stronger as pandemic impact decreases: Ajay Piramal July 8, 2022: Pharmaceutical businesses that have a strong track record of quality compliance and can remain agile towards new regulatory requirements, will emerge stronger as the impact of the pandemic decreases, according to Piramal Enterprises Ltd NSE -0.27 % Chairman Ajay G Piramal.
Global Injections
FDA Grants Emergency Authorization for Novavax COVID VaccineJuly 13, 2022: Americans could soon have a fourth option for COVID-19 vaccines after the FDA today granted emergency use authorization to a two-shot vaccine from Novavax. The vaccine is authorized for adults only.
New Algorithm Can ID Critical Cancer Mutations in DNAJuly 12, 2022: Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.
Amazon Involved With New Cancer Vaccine Clinical Trial
July 13, 2022: Amazon is working with the Fred Hutchinson Cancer Research Center to develop cancer vaccines in a new clinical trial.
Digital Mental Health Companies Draw Scrutiny and Growing Concerns
July 8, 2022: When Pat Paulson’s son told her he was feeling anxious and depressed at college, Paulson went through her Blue Cross Blue Shield provider directory and started calling mental health therapists. No providers in the Wisconsin city where her son’s university is located had openings.
US considers over-the-counter birth control pills for first time
July 12, 2022: For the first time in the US, a pharmaceutical firm has asked to be allowed to sell birth control pills over the counter.
Zero Covid holds danger for China's Xi
July 8, 2022: Halfway to the capital, officials wearing protective clothing stopped the train, boarded and announced on megaphones that everyone must get off because one of the passengers had been linked to a Covid cluster.
PSAIIF PILL
Private sector must get involved in primary healthcare: Health secretary
Mumbai, July 15, 2022: Union health secretary Rajesh Bhushan has asserted that private sector is a critical player in the overall healthcare system in the country. He added that a large part of health burden is borne by the private sector providers.
NPPA’s expert panel recommends retail price fixation of sitagliptin combinations in further 26 applications
New Delhi, July 15, 2022: Even as the Indian market has started seeing launch of fixed dose combinations (FDCs) comprising anti-diabetic drug sitagliptin, as the patent of Merck Sharp and Dohme (MSD) is expected to expire this month, the expert panel of National Pharmaceutical Pricing Authority (NPPA) has further recommended retail price for the 26 more applications in 11 FDCs of sitagliptin in its latest meeting. The drug price regulator’s decision is expected to bring down the price of the FDC by around 50 per cent on the patented compound of the FDC.
Frequently Asked Questions
5 Blood Donation Benefits You Should Know
Blood donation is a community responsibility. About one in seven people entering a hospital needs blood. Only 37 percent of our country’s population is eligible to give blood, and less than 10 percent of those who can donate actually do donate annually. What if everyone eligible to donate became complacent and decide they didn’t need to donate because someone else would? Read More>>>
SUBSCRIBER'S SYMPTOM
Oral Care: Does India need a robust dental care policy?
July 11, 2022: The mouth is the window to the entire body. Oral and dental issues are recognized by WHO as a significant threat to public health that diminishes the quality of life by impairing the individual’s everyday functioning. Oral disorders are chronic, non-communicable diseases that not only inflict agony and discomfort but can also result in lost work hours, consequently negatively impacting the economy as a whole.
Consumer Online Foundation: The first and only organisation certified as per international standard ISO 9001:2015 for Consumer Complaint Redressal Services
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Blog Addicts
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Thank You! PSA-India for helping the people to know their medication closely.
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