Editor in Chief Dr KK Aggarwal, Padma Shri Awardee                                                                          Dated:27th September,2019

‘TB Harega Desh Jeetega’: new TB control campaign launched by the Health minister

Dr. Harsh Vardhan, Union Minister for Health and Family Welfare yesterday launched the new TB Harega Desh Jeetega Campaign, along with the National TB Prevalence Survey. Highlighting some of the key features of the new TB control campaign, Dr Harsh Vardhan stated its three strong pillars include clinical approach, public health component and active community participation.Other supporting elements of the campaign comprise private sector engagement, patient support, and political and administrative commitment at all levels. He added that the Government is committed to ensuring all patients, irrespective of where they seek care (private sector included), receive free-of-cost, high quality TB care. “In line with the Honourable Prime Minister’s vision, we have introduced pivotal initiatives that are changing the way we diagnose, treat and prevent TB, and are on track to achieving our target of a TB-free India by 2025, much ahead of the global target of 2030,” he said.

The new TB campaign aims to improve and expand the reach of TB care services across the country, by 2022. This includes preventive and promotive approaches, and proposes potentially transformative interventions such as engagement with private sector health care providers, inter-ministerial partnerships, corporate sector engagement, latent TB infection management, and community engagement. The interventions will be accompanied by a comprehensive, mass media and communications campaign to generate awareness about the disease and the free treatment services available under the government program… (PIB, Sept. 25, 2019)

Ranitidine safety alert: DCGI should have put the drug on temporary hold till it had been certified safe
Vide a notification F. No. 12-03/19/DC (Safety-007), the DCGI has issued a directive to all the States and UT Drug controllers regarding a nitrosamine impurity, N-nitrosodimethylamine (NDMA) in ranitidine.

Ranitidine is an OTC drug. It is also one of the most commonly prescribed drugs for heartburn and GERD.

The DCGI has asked all Drug controllers of states and UTs to communicate to the manufacturers of ranitidine API & formulations under their jurisdiction “to verify their products and take appropriate measures to ensure patient safety”.

As a precautionary measure, this is a welcome step. But, the safety alert issued by the office of DCGI is a serious matter. It shows that even the DCGI is concerned about this issue. ....read more

A student’s health and well-being can impact educational progress: Doctors too can help support academic success
The American Academy of Pediatrics (AAP) has published a clinical report on how pediatricians too can help children who do not making expected progress in school.

According to AAP, while traditionally, the school system has the responsibility for evaluation and management of children who have academic problems, pediatricians too can play an important role in a child’s academic success as part of a multidisciplinary team comprising of family, school and other related professionals.

Academic dysfunction may be a symptom of various health issues and psychosocial factors such as cognitive dysfunctions, emotional difficulties and disorders, autism spectrum disorder, adversity or trauma, stress in important relationships in and out of the home, attention deficits and undiagnosed or poorly-controlled chronic illnesses such as asthma and diabetes. ....read more

Why do we not touch papers, books and people with our feet?
In every traditional Gurukul, no studies start without chanting the following

Saraswati namasthubhyam
Varade kaama roopini
Vidyaarambham karishyaami
Sidhirbhavatu me sadaa ....read more

Healthcare News Monitor

TB cases increased by 16 per cent in India in 2018: Report
ET Healthworld- PTI

New Delhi, Sep 25 : India witnessed 16 per cent increase in the number of tuberculosis cases in 2018 against the previous year's figure of 18 lakh even though around eight lakh patients went undetected, according to an official report released on Wednesday. According to the 'India TB Report 2019', India accounts for a quarter of the Global TB burden with an estimated 27 lakh new cases in the year 2018. Of that 21.5 lakh TB cases were notified to the Revised National Tuberculosis Control Programme (RNTCP), compared to 18 lakh in 2017 -- an increase of 16 per cent in one year. Among the notified, treatment was initiated for about 19.1 lakh cases (90%), across both public and private sectors. "The burden of undetected tuberculosis is large in many settings, especially in high-risk groups which are identified under the country's National Strategic Plan (2017-25)," the report stated. According to the report, of the total notifications, 25 per cent (5.4 lakh) cases were reported from the private sector, a 40 per cent increase from last year. This indicates an increased engagement with private sector providers and patients seeking care from them.

In a First, India To Have Defined List of OTC Drugs: Here’s What It Means For You!
The Better India - Vidya Raja

How many of us have popped pills for a headache without thinking about the dosage, strength of the drug, or even understanding the cause of the headache? We assume that the pill will cure us of the symptom (the ache), and the cause (which we don’t yet know), without causing any side effects (which we are ignorant about). A survey of 20,000 people in 10 cities across India, revealed that almost 52 per cent of them indulged in self-medication. While this can give rise to a whole host of issues, the focus of this article is to see how the purchase of Over The Counter (OTC) drugs can be regulated. What are OTC drugs? These are drugs that do not require, by law, a prescription from a doctor to be sold and include medicines that your neighbourhood pharmacy hands you when you describe your condition. Most OTC drugs are usually categorised into pain relievers, cough remedies, anti-allergens, laxatives, vitamins, antacids etc. Why do they need to be regulated? Self-medication is not just extremely risky but in some situations can prove to be fatal and land you in the hospital. One repercussion of taking these OTC drugs is that the underlying condition that caused you discomfort and pain remains undiagnosed. While it may be treated immediately, it continues to linger in the long term.

GSK suspends Ranitidine distribution in India, regulators seek drug testing data from pharma cos
moneycontrol - Viswanath Pilla

Drugmaker GlaxoSmithKline Pharmaceuticals (GSK) on September 25 said it has suspended the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations. GSK sells Ranitidine Hydrochloride tablets under popular brand name Zinetac in India. GSK said it has been contacted by regulatory authorities regarding the detection of nitrosamine impurity called N-nitrosodimethylamine (NDMA) in ranitidine products. NDMA has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans. GSK made the decision based on the information received and correspondence with regulatory authorities, the company said. "GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers. Patient safety remains our utmost priority and we are taking this issue very seriously,” the company said.

Govt plans to set up body to regulate medical devices sector
Business Standard – Veena Mani & Sanjeeb Mukherjee

The government is planning to set up a Medical Devices Authority (MDA) for the entire spectrum in the medical devices sector — gauges, weighing machines, orthopaedic implants or whatever. It will, however, not have powers on pricing. That will continue to be vested with National Pharmaceutical Pricing Authority (NPPA), senior officials said. The proposed body will be separate from the Central Drugs Control Standard Organisation (CDSCO), which will continue to be the regulator for drugs. The Bureau of Indian Standards (BIS) will still frame guidelines but these would be regulated by MDA. The arrangement would be on the lines of food items, where BIS designs the standards but these are enforced by the Food Safety and Standards Authority of India. For, BIS itself doesn’t have implementing powers, said a senior government official who is working on the proposed MDA. He said the body would comprise representatives from the industry, policy makers and active medical practitioners. It will get its role, powers and objectives from a Medical Devices Act, whose provisions are being framed. “Government agencies, along with BIS, are formulating the Act. The draft has been made and BIS has already made 1,325 standards for more than 1,000 product lines,” added the official. NITI Aayog is also involved in the process. The plan is to stop using norms borrowed from the American regulator, the Food and Drugs Administration (FDA), for procurement by state and central governments once MDA is put in place. Currently, medical devices are the responsibility of the central drug regulator but are treated akin to.

Govt may move drugs made from local APIs out of price control list
Mint – Leroy Leo

The government is considering a proposal to keep medicines made from locally produced ingredients out of price control to promote domestic manufacturing and reduce the dependence of Indian companies on imports, two senior government officials said, on the condition of anonymity. “What the government is considering is that if an Indian company manufactures a tablet made from a locally-manufactured API (active pharmaceutical ingredient), then the drug will be exempted from DPCO (Drug Price Control Order). However, drugs made from APIs that are imported will be under DPCO," one of the officials said. APIs, or bulk drugs, are key raw material from which medicines are made. Currently, India imports a majority of its APIs, especially from China. The Centre is examining ways to tackle the challenges likely to come up, including how to verify claims about the use of locally sourced APIs, the second official added. The proposal was made during a meeting of a committee led by Mansukh Lal Mandaviya, minister of state for chemicals and fertilizers last month, the first official said. The panel, which includes pharmaceutical secretary P.D. Vaghela, the drug controller general of India V.G. Somani and officials from related government departments, is tasked with giving suggestions to boost bulk drug manufacturing in India. In 2018-19, Indian pharmaceutical companies imported bulk drugs and intermediates worth $2.4 billion from China, which was about 68% of total imports of the raw material, the government had informed the Lok Sabha last month. Experts concur that while implementation of the move could be a challenge, if successfully implemented, it could boost domestic manufacturing of APIs.

PvPI asks stakeholders to report ADRs due to irrational usage of nutraceuticals
Pharmabiz India - Shardul Nautiyal

In view of the increasing incidences of adverse drug reactions (ADRs) due to irrational usage of nutraceuticals, the Pharmacovigilance Programme of India (PvPI) has urged the stakeholders to utilise channels of reporting ADRs developed by Indian Pharmacopoeia Commission (IPC). Indian Council of Medical Research-National Institute of Nutrition (ICMR-NIN), Hyderabad is one of the PvPI collaborating centres for monitoring the safety of nutraceuticals. Currently, PvPI receives a very limited number of ADRs related to the use of nutraceuticals, health and food supplements. Therefore, it has been urged to all stakeholders including clinicians, nurses, pharmacists, other allied health workers and public to report all adverse events associated with nutraceuticals, health and food supplements. PvPI has urged to utilise channels of reporting such events like PvPI Forms (Suspected ADR Reporting Form/ Medicines Side-Effects Reporting Form), Email address - (icsr.nccpvpi@gmail.com), (pvpi.compat@gmail.com), PvPI Helpline (1800-180-3024) and Mobile App (ADR PvPI). Ghaziabad based IPC is functioning as a National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) launched in 2010. Last year, the Union health ministry came out with suspected ADR form for healthcare professionals for reporting adverse drug reactions (ADRs) towards focused Pharmacovigilance (PV). It also came out with medicines side-effect reporting form for approved drugs in the country besides a toll free helpline number in the interest of patient safety. Union health ministry has also tasked 270 ADR Monitoring Centres (AMCs) existing in the country to establish clinical evidence between the drug and the adverse drug reaction through a robust system of causality assessment.

Kerala woman who underwent chemotherapy after wrong diagnosis to be given Rs 3L compensation
ET Healthworld- PTI

Thiruvananthapuram: The Kerala Government on Wednesday decided to give a compensation of Rs three lakh to a woman who underwent chemotherapy at the Kottayam medical college hospital early this year after she was wrongly diagnosed to be suffering from cancer. The decision in this regard was taken at the cabinet meeting chaired by Chief Minister Pinarayi Vijayan. The amount would be released from the Chief Minister's distress relief fund, a press release from the Chief Minister's office said. The medical expenses incurred by the woman for undergoing chemotherapy, the consequent health issues and the mental trauma suffered by her was taken into consideration while deciding on the compensation to the 38-year-old woman. Rajani was given chemotherapy treatment after a test conducted at a private lab revealed a small area of malignancy on her breast.

Pharmacists must play crucial role in safeguarding patient safety by enabling proper usage of medicine: DPA
Pharmabiz India

Marking the celebrations of World Pharmacists Day on 25th September 2019, the Doctor of Pharmacy Association (DPA) members embarked on awareness campaigns on the role a pharmacists in healthcare sector. Dr. Sai Kumar Katam, National president of DPA stressed on the significant role a pharmacists can play in safeguarding the safety of patients by way of advocating the usage of proper dose of medicines and reducing the incidences of adverse drug reactions amongst the patients. “This year commemorating the World Pharmacy Day celebrations we have launched awareness campaigns among the public about the important role a pharmacy professional can play in the public health sector to safeguard the safety of a patient. As part of this we organised the campaign with a new theme called ‘Safe and effective medicines for all',” said Dr Katam. The DPA president observed that this year’s theme is designed to promote pharmacists’ crucial role in safeguarding patient safety through improving medicines use and reducing medication errors. “Pharmacists are the most accessible health care professionals globally and are uniquely trained to be able to impact medication safety at the individual patient level through medication management skills that are part of the clinical pharmacist's role. Medicines today have great power to heal and to improve the quality of life but medicines also may do serious harm if not taken correctly. This is where the role of the pharmacist is most important. We ensure access to safe use of medicines and its appropriate use; improve adherence, and coordinate care transitions and so much more. Today, more than ever, pharmacists are charged with the responsibility to ensure safety and security of a patient while using the medicine and ensure it does not cause any harm,” observed the DPA president.