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HUL announced the next step in the evolution of its skin care portfolio, with the rebranding of its flagship brand Fair & Lovely. Taking forward the brand’s journey towards a more inclusive vision of beauty, the company will stop using the word ‘Fair’ in the brand name ‘Fair & Lovely’. The new name is awaiting regulatory approvals and we expect to change the name in the next few months.

Over the last decade, Fair & Lovely’s advertising has evolved to communicate a message of women’s empowerment. The brand’s vision is to adopt a holistic approach to beauty that cares for people, that must be inclusive and diverse - for everyone, everywhere. The brand is committed to celebrating all skin tones.

In early 2019, the brand’s communication moved away from the benefits of fairness, whitening and skin lightening, towards glow, even tone, skin clarity and radiance, which are holistic measures of healthy skin. HUL also removed from Fair & Lovely’s packaging, words such as ‘fair/fairness’, ‘white/whitening’, and ‘light/lightening’ that could indicate a fairness-led transformation. The cameo with two faces showing shade transformation, as well as the shade guides were removed from the packs. The Company will continue to evolve its advertising, to feature women of different skin tones, representative of the variety of beauty across India.

Sanjiv Mehta, Chairman and Managing Director, HUL said, “We are making our skin care portfolio more inclusive and want to lead the celebration of a more diverse portrayal of beauty. In 2019, we removed the two faced cameo as well as the shade guides from the packaging of Fair & Lovely and the brand communication progressed from fairness to glow which is a more holistic and inclusive measure of healthy skin. These changes were very well received by our consumers. We now announce that we will remove the word ‘Fair’ from our brand name Fair & Lovely. The new name is awaiting regulatory approvals, and the pack with the revised name will be available in the market in the next few months.”

Fair & Lovely is based on pioneering technology that has made multiple skin health benefits available to millions of consumers at an affordable price. The brand has been progressively changing its formulation, and includes other vitamins like B6, C & E, allantoin, known to improve skin health and protect the skin from external aggressors, UV rays and environmental pollution.

The product is designed to improve skin barrier function, improve skin firmness and smoothen skin texture - all of which help enhance radiance and glow holistically. The brand has never been and is not a bleaching product. In addition to the changes to Fair & Lovely, the rest of our skin care portfolio will also reflect the new vision of positive beauty.

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EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.

Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.

From 30 April 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorisation application on 5 June

The assessment of the dossier has now concluded with today’s recommendation, which is mainly based on data from study NIAID-ACTT-11, sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), plus supporting data from other studies on remdesivir.

Study NIAID-ACTT-1 evaluated the effectiveness of a planned 10-day course of remdesivir in over 1,000 hospitalised patients with COVID-19. Remdesivir was compared with placebo (a dummy treatment) and the main measure of effectiveness was patients’ time to recovery (defined as no longer being hospitalised and/or requiring home oxygen or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care).

Overall, the study showed that patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given placebo. This effect was not observed in patients with mild to moderate disease: time to recovery was 5 days for both the remdesivir group and the placebo group. For patients with severe disease, who constituted approximately 90% of the study population, time to recovery was 12 days in the remdesivir group and 18 days in the placebo group. However, no difference was seen in time to recovery in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation). Data on the proportion of patients who died up to 28 days after starting treatment are currently being collected for final analysis.

Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease. Remdesivir is given by infusion (drip) into a vein and its use is limited to healthcare facilities in which patients can be monitored closely; liver and kidney function should be monitored before and during treatment, as appropriate. Treatment should start with a 200-mg infusion on the first day, followed by one 100-mg infusion a day for at least 4 days and no more than 9 days.

Remdesivir is recommended for a conditional marketing authorisation, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need, including in emergency situations in response to public health threats such as the current pandemic. This type of approval allows the Agency to recommend a medicine for marketing authorisation with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent to the fact that not all the data are yet available.

In order to better characterise the effectiveness and safety of remdesivir, the company will have to submit the final reports of the remdesivir studies to the Agency by December 2020, and further data on the quality of the medicine, as well as the final data on mortality, by August 2020. As for all medicines, a risk management plan (RMP) will ensure rigorous safety monitoring of remdesivir once authorised across the EU. Further efficacy and safety data will be collected through on-going studies and post-marketing reports and will be regularly reviewed by the CHMP and EMA’s safety committee (PRAC). Since April 2020, the PRAC has also been reviewing safety data on patients treated outside clinical studies, which are being submitted as monthly safety reports; these will continue to be submitted and assessed after the medicine is on the market.

During the assessment of remdesivir, the CHMP had the support of experts from the COVID-19 EMA pandemic task force (COVID-ETF), which was established to bring together the most relevant expertise from the European medicines regulatory network to assist Member States and the European Commission in dealing with the development, authorisation and safety monitoring of medicines and vaccines against COVID-19.

The European Commission, which was kept informed by EMA throughout the evaluation, will fast-track the decision-making process and aims to grant a decision on the conditional marketing authorisation for remdesivir in the coming week, allowing the product to be marketed in the EU.

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Hetero, one of India’s leading generic pharmaceutical companies, announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘COVIFOR’ in India.

Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “In the light of increasing COVID-19 cases in India, the approval of ‘COVIFOR’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against COVID-19. This product is made indigenously in line with ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”

The drug ‘Remdesivir’ has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalized with severe symptoms of the disease. COVIFOR (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner.

The product is launched under a licensing agreement with Gilead Sciences Inc. to expand access to COVID-19 treatment in low and middle-income countries.

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In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals got approval of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.

Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart diseasewith mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement.Of most importance, Favipiravir has shown clinical improvementof up to 88% in COVID-19 mild to moderate COVID 19 cases.

Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team.Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.

Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, “This approval comes at a time when cases in India are spiralling like never before,putting a tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu® will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option.”

He added, “FabiFlu® has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications. Glenmark will work closely with the government and medical community to make FabiFlu® quickly accessible to patients across the country.”

Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.

Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use.The drug will be available as a prescription-based medicationfor INR 103/tablet,with recommended dose being1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.

Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.

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16 June 2020

FDA approves JUVEDERM VOLUMA XC for enhancement of the Chin Region

Allergan Aesthetics got the FDA approval of JUVÉDERM® VOLUMA™ XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21. As the category leader, the JUVÉDERM® collection of Fillers has the broadest portfolio of specifically tailored treatment options, and this latest approval marks their fifth approved indication in the U.S.
As demand for medical supplies soars worldwide in the fight against Covid-19, there is a parallel risk of substandard and counterfeit medicines in the global market. With India being one of the world's largest producers of medical supplies, there is an urgent need to bring in strong anti-counterfeiting measures which will be addressed at Messe Frankfurt’s upcoming conference - Pharmasafe India 2020.

Together with healthcare workers on the frontline, the pharmaceutical industry has been actively playing a crucial role and strengthening efforts to ensure best medical services in the battle against Covid-19. However, the trade of counterfeit medicines, which can pose a direct threat to public health and life, has found resurgence in the wake of on-going pandemic. The recent warnings issued by the World Health Organisation indicate that a growing number of fake medicines linked to coronavirus are on sale in developing countries. There have already been multiple incidents reported on the sale of counterfeit facemasks, substandard hand sanitisers, substandard PPE's as well as counterfeit anti-viral drugs to unsuspecting consumers.

With an aim to draw attention to the latest developments in the field of anti-counterfeiting technologies for the pharma industry, Messe Frankfurt India will bring key anti-counterfeit solution providers for dialog with the pharma sector at its highly influential Pharmasafe India 2020 conference. The 4th edition of the conference, which was earlier scheduled in April, has now been pushed ahead due to the nationwide lockdown and the new dates will be announced in the coming weeks, when the industry can safely and surely come together to address and reinforce measures for this global issue.

Ahead of the conference scheduled this year, Messe Frankfurt is also organising a series of Webinars during the lockdown period to serve the industry with valuable insights from an international panel of experts and thereby helping the industry in charting anti-counterfeiting strategies in the current situation. While the webinars will bring attention to immediate topics of relooking at patient safety by eliminating substandard products in the wake of global outbreak, the organiser is working towards addressing burning topics around Covid-19 at the Pharmasafe India conference taking place later this year, surrounding the counterfeit market such as the race for coronavirus vaccine and government initiatives to prevent vaccine counterfeit, Operation Pangea 13: key findings and importance of consolidated global efforts in identifying counterfeit networks, strengthening supply chain and traceability technology to curb counterfeit amid pandemic, mishandling of medicines and addressing the issue of improper vaccine storage and how the pandemic is reshaping brand protection.

The conference has drawn strong support from leading associations in the pharmaceutical industry including Authentication Solution Providers' Association (ASPA), Indian Drug Manufacturers' Association (IDMA), Cell for IPR Promotion and Management (CIPAM) and Chamber of Business Leaders.

According to a study conducted by the OECD and the European Union Intellectual Property Office, trade in counterfeit pharmaceutical products worldwide is worth just over €4bn. The longer the pandemic lasts, the more strain supply chains and distribution channels will undergo, making it easy for counterfeits or sub-standard medical products to enter the market. It is crucial to simultaneously focus on anti-counterfeiting and brand protection strategies which Pharmasafe India 2020 together with its webinar series aim to achieve through the combined efforts of technology experts, decision-makers and the Indian pharma industry.

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AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that it will partner with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax’ coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax’ capacity to deliver doses in 2020 and 2021.

“We are quickly ramping up to successfully deliver this vital vaccine component to Novavax,” says AGC Biologics’ CEO Patricio Massera. “The urgency to help produce a vaccine to combat COVID-19 could not be higher.”

“AGC Biologics’ mission is to work side-by-side with our partners to produce life-saving and extending products,” says Mark Womack, CBO of AGC Biologics. “Partnering with Novavax to manufacture this vaccine component is an amazing opportunity to make a profoundly positive difference.”

“We have been impressed with AGC Biologics’ level of collaboration and commitment,” says Timothy J. Hahn, SVP, Process Technology at Novavax. “They are an important strategic partner in expanding our supply chain of adjuvant for NVX-CoV2373 and for other vaccines being developed at Novavax, including our recombinant seasonal influenza vaccine, NanoFlu.”

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Novartis announced updated results from the landmark COMBI-AD clinical trial, demonstrating that treatment with Tafinlar® (dabrafenib) and Mekinist® (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma1. Researchers reported that 52% (95% CI, 48%-58%) of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years.

Among patients in the study’s placebo arm 36% (95% CI, 32%-41%) were alive and relapse-free at the time of this analysis, generally consistent with typical melanoma relapse-free survival rates seen among patients with resected stage III disease without treatment. Consistent RFS benefit was observed across all AJCC 7 stage III subgroups.
Median RFS, or the length of time when 50% of patients are still alive and relapse-free, was not yet reached at the 5-year data cut-off for patients on Tafinlar + Mekinist treatment, suggesting long-term benefit of targeted therapy in the adjuvant (post-surgical) setting (NR; 95% CI, 47.9 mo-NR). Median RFS was 16.6 months for patients taking a placebo (95% CI, 12.7-22.1 mo). Treatment with Tafinlar + Mekinist reduced the risk of relapse or death by 49% compared to placebo (hazard ratio [HR] 0.51; 95% CI 0.42, 0.61)1.

“Our goal as clinicians is to give our stage III patients the best chance for relapse-free survival,” said Prof. Axel Hauschild, MD, Professor of Dermatology, University Hospital Schleswig-Holstein, Germany. “Results from COMBI-AD show that adjuvant treatment with Tafinlar + Mekinist after surgical resection gives melanoma patients the chance for long-term relapse-free survival. Five years is a clinically and emotionally significant milestone for patients. Recurrent BRAF+ melanoma, once spread to other organs, can be more dangerous and difficult to treat. The durable, long-term results seen among patients in the COMBI-AD trial clearly point to the important role targeted therapy plays in the adjuvant setting.”

The COMBI-AD study results are drawn from a prospective analysis of 870 patients with BRAF V600-mutated melanoma treated with Tafinlar + Mekinist after their surgery. This study represents the largest collection of data and longest follow-up to date in this patient population treated with targeted therapy2. The findings were presented at the ASCO20 Virtual Scientific Program (Abstract #10001).

“The five-year survival mark is an important and predictive milestone for people with melanoma and the doctors who care for them,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “We see an almost 50% risk reduction in melanoma relapse or death in the COMBI-AD data announced today, and we believe patients will find this information helpful in choosing a treatment after surgery. We thank the patients and their families who participated in this long-term clinical trial. Their participation and commitment is helping the community learn how a BRAF-targeted therapy can reimagine outcomes for patients with resectable stage III melanoma.”

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PHD Chamber of Commerce & Industry, Health Committee organized an interactive video conference of series on "Digital Health: The Future: Telemedicine-Where do We Stand Today" on 29th May 2020.

During the discussions with experts from hospitals, MCI, Industry, academia and the radiology and health insurance experts thanked the Govt for guidelines on Telemedicine making it legal for the doctors in India while demanding the Regulatory framework for Telemedicine for International patients as well. They also opined that with AI under supervision of the Clinicians, Telemedicine can extend health support to the rural patients and we could see 20-25% of healthcare being provided through Telemedicine
The eminent panellists of the webinar were Dr. N. Subramanian, Chairman, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals, Mr. Aditya Berlia, Co-Founder & Pro Chancellor, Apeejay Satya University, Dr. Hans Raj Baweja, Chairman, Ethics Committee, Medical Council of India, Dr. Harsh Mahajan, Founder & Chief Radiologist, Mahajan Imaging, Dr. Puneet Girdhar, Sr. Director & Spine Surgeon, BLK Super speciality Hospital, Mr. S K Mehra, Managing Director & CEO, Health Insurance TPA of India.

Dr. N. Subramanian, Chairman, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals welcomed all the panellist and said that telemedicine plays a very important role in our lives to reach out to everyone and it is expanding & getting better every year. The risk of NCDs are so high for the treating doctors that the awareness and prevention is the only way to avoid complications where telemedicine and AI play a major role to make the data available and stratifying the risks. It can also manage the algorithms in treating patients with high risk demographics where the Government has the access to real time data and the changing patterns of the disease. Dr. Subramanian advised young practitioners who are keen to adopt the telemedicine technology that it is very important to have certain amount of discipline and they should establish a relationship and trust with the patients esp. for incase of Telemedicine.

Dr Harsh Mahajan, Founder & Managing Director, Mahajan Imaging while briefing about the tele-radiology said that the computing and internet availability improves exponentially the effectiveness of Telemedicine as also reduces the cost drastically of healthcare delivery. He said we will be able to serve the underprivileged sections of the society and remote areas through Telemedicine. He further said that with the advent of Corona, telemedicine has become the necessity where technology helped us a lot to fight this crisis. He also told that telemedicine and AI make work easier and it will become indispensable in coming years but it has to be under supervision of a clinician. Answering to one of the questions from audience, Dr. Mahajan said that telemedicine is here to grow exponentially and serve the multiple purpose like diagnosis, training, education and serve the agenda of preventive measurement. He further added that apart from teleradiology, telemedicine can be used in digital pathology, dermatology, ophthalmology and many other segments.

Mr. Aditya Berlia, Co-Founder & Pro Chancellor, Apeejay Satya University said that the doctor to patient ration in urban area is around 1:10,000 and in rural area it is worst at 1:30,00,00 and this is a worldwide scenario. The Covid-19 has changed the patient & doctor psychology at large and 20-25% medical system will move to telemedicine in coming years. He also said that Covid 19 had given a massive boost to telemedicine and there is an urgent intervention needed from the regulatory part as there is a problem with the data collection part. He further added that in next one year there will be a tremendous use of telemedicine for quick follow-up consultations, consultations by patients who panic and 2nd opinion consultations for referral patients and if we are able to do this then it is a phenomenal achievement.

Dr. Hans Raj Baweja, Chairman, Ethics Committee, Medical Council of India said that there were lot of legal limitations we faced before Covid era as telemedicine is existing and practiced in other countries but never recognised in India. Its only due to this Corona pandemic on 25th March 2020 the telemedicine guidelines were finalised which says that every doctor in India can go on telemedicine platform in India. Explaining the key points of telemedicine guidelines, like mandatory patient consent, mandatory patient identity as it is difficult to identify the patient in audio consultations, taking of history & entering all the details in the prescription, Dr. Baweja said that it is mandatory for doctors also to introduce themselves at the time of consultation and only generic medicines should be prescribed.

Dr. Puneet Girdhar, Sr. Director & Spine Surgeon, BLK Super speciality Hospital said that in the past everyone knew about telemedicine but due to legal limitations, patient psychology and other complications very few were using it and now with the Corona Virus hitting changed even hospitals have come up with their individual telemedicine apps.

Mr. S.K. Mehra, Managing Director & CEO Health Insurance TPA of India said that there’s huge demand of Telemedicine among doctors in coming years. He said this is the right time to start and set some protocols & regulations, which will also help in the expansion of the Telemedicine. He said this concept will certainly help the senior citizens, where they require general consultation or normal follow up for the medicine. Mr. Mehra also explained about the existing insurance policies and the important aspects of telemedicine consultation coverage in the insurance.

While moderating the session Dr. Deep Goel, Senior Director, Dr. B L Kapur Memorial Hospital said that the mother earth is under repair and the social distancing will be the new normal in coming times.

Mr Vivek Seigell, Principal Director Health, PHD Chamber who moderated the session with Dr Deep Goel said that the recommendations and details of the discussions held will be sent to NITI AAYOG as policy inputs on various aspects of Telemedicine esp. for the consulting for International Patients.

Dr. Subramanian, Chairman, Health Committee, PHDCCI gave the Vote of Thanks and the webinar was attended by more than 100 delegates.

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COVID-19 positive individuals who are asymptomatic do not have the potential to infect others because they have a low “virus load” compared to those who are symptomatic, said Health director-general Datuk Dr Noor Hisham Abdullah reported by Bernama.

He, however, said that infectivity could occur two days before the affected individual showed symptoms.

“So, we need to differentiate that the ones without symptoms do not have any problems as there’s no infectivity. But we found that those with symptoms and two days before having those symptoms they could infect others,” he said at the daily press conference on COVID-19 on 31st May, 2020 in Malaysia.

He said that the first week of being symptomatic was when the virus was active enough to infect others, but if the individual was isolated for between eight to 10 days, or 14 days as is being done by the government now, the infectivity rate can be reduced to almost zero.

“As for those who are asymptomatic, perhaps they won’t be able to infect others within 14 days. But infection can happen two days before the symptomatic period. So, if we can isolate them we can break the COVID-19 chain of transmission,” he said.

Meanwhile, Dr Noor Hisham said that tomorrow the Ministry of Health (MOH) would share its model regarding the projection for COVID-19 cases in the last one month, today and in the future.

“So for cases involving Malaysians, we found there was adherence to standard operating procedure (SOP) and when we comply with the SOP, it means the R-nought (RO) is less than 0.3 percent. (RO refers to the infectivity rate).

“But for non-Malaysians, if we minus the immigration detention depot and import cases, we find the RO is still about 0.3 percent and we are still monitoring daily the development among Malaysians and non-Malaysians,” he said.

He said what was important was for the MOH to focus on non-Malaysians so that they too complied with the SOP.

However, he said several constraints needed to be focused on, such as accommodation and environment of the foreigners, while employers also needed to play their role in ensuring the foreign workers complied with government directives as well as to take preventive measures and maintain cleanliness. (Bernama)

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