New drug to fight migraine shows promise

A new drug to treat migraines has shown promise in a large-scale clinical trial, offering hope to people unable to use current treatment options.

The drug, ubrogepant, showed greater rates of pain and symptom relief from migraine compared to a placebo, with more than 20% of participants given the drug reporting to be pain-free within two hours and more than 34% relieved of the most bothersome symptoms linked to migraine, which include light and noise sensitivity. This is compared to 14% and 27%, respectively, from the placebo… (CNN, November 19, 2019)

Healthcare News Monitor

Cadila Healthcare gets USFDA approval for Isosorbide Dinitrate, Desonide; shares volatile

moneycontrol

Cadila Healthcare on November 21 said Zydus Cadila has received final approvals from the US health regulator for Isosorbide Dinitrate Tablets and Desonide Cream. Shares of the company were on a shaky track on BSE. The stock traded in the red in the early trade, climbed 2 percent after some time and turned flat again. Around 11:35 hours IST, shares of the company traded 0.40 percent up at Rs 250.05 on BSE. "Zydus Cadila has received the final approval from the USFDA to market lsosorbide Dinitrate Tablets USP (US RLD — Isordil Tablet) in the strengths of 5 mg, 10 mg, 20 mg, 30 mg and 40 mg. The group also received the final approval for Desonide Cream (US RLD — Desonide Cream), 0.05 percent," Cadila Healthcare said in a regulatory filing. Isosorbide Dinitrate Tablets are used to prevent attacks of chest pain (angina). lt dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump. It will be manufactured at the groups formulations manufacturing facility at Baddi, the regulatory filing said. Desonide Cream is a mild corticosteroid, used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash) to reduce swelling, itching and redness that can occur in these types of conditions. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, said the regulatory filing.

Standardization- need of the hour for Traditional Medicines in India : Dr R B Smarta

ET Healthworld

Traditional Medicines (TM) have great potential to grow in the country. Factors that would support this growth include increasing public awareness on the natural benefits of traditional medicines, who are shying away from chemical drugs, increased awareness on importance of prevention, growth in e-commerce and mobile internet, growth in disposable incomes etc. Time has come when chemical products through pharma and herbal products through Nutraceuticals, Ayurceuticals and phyto-pharmaceuticals will co-exist. In view of this, pharma companies have started their own division of traditional medicines. Modern medicines mitigate diseases directly whereas TM such as Ayurveda or Yunani builds upon the immunity of the body that fights the diseases. It is interesting to note that TMs operates on a similar definition of health as is accepted by WHO ‘Health is the state of complete physical, mental and social well being and not merely the absence of disease or infirmity.” Traditional medicines encompass the traditional methods of diagnosis (such as Nadi shastra); products derived from herbs, elements of nature and animals; body healing techniques based on faith and belief; acupuncture, magnetic therapies etc. The global TM market is expected to generate revenue of $ 196.87 billion by 2025.According to US-based The Global Industry Analysts Inc., the global herbal medicine market size was valued at $ 71.19 billion in 2016 and is projected to reach $115 billion by 2020.

Vardhan reviews preparedness of states for roll out of IMI 2.0 from Dec 2

Business Standard – PTI

Union Health minister Harsh Vardhan on Thursday reviewed preparedness of various states for the rollout of the second phase of an intensified vaccination campaign on December 2, with special focus on improving coverage in areas with "low" immunization. The minister reviewed the preparedness of states for rollout of Intensified Mission Indradhanush (IMI) 2.0. Vardhan said the IMI 2.0 aims to achieve full immunization by targeting each and every child below the age of two years and all pregnant women still uncovered or partially covered in 271 districts of the country and 652 blocks of Uttar Pradesh and Bihar. According to a government data, 260 lakh children are born every year and an estimated 31 lakh out of them would not receive complete rounds of vaccination in the first year of their life due to various reasons. Interacting with state principal secretaries, National Health Mission directors and immunization officers of states during a video-conference, Vardhan emphasised the importance of immunisation of children and pregnant women as part of the IMI 2.0 and the high priority bring accorded by the Health Ministry for achieving full immunisation coverage targets. "While we are required to achieve 90 per cent immunisation coverage target, we should all aim to ensure that not even one child dies of vaccine preventable diseases, especially, when we have a basket of vaccines as part of our routine Universal Immunisation Program (UIP)," Vardhan said.

Indian excipient industry to approach DCGI to curb irrational usage of excipients in domestic market

Pharmabiz India - Shardul Nautiyal

The Indian excipient industry is planning to approach the Drugs Controller General of India (DCGI) to frame India specific guidelines to curb irrational usage of excipients in the domestic market. There cannot be dual set of specifications and guidelines for the international and domestic market in a scenario where 70 per cent of excipients are imported, industry experts pinpoint. According to industry sources, many foreign players have set up manufacturing facilities in the country which is also complemented with the ongoing effort of International Pharmaceutical Excipient Council (IPEC) to harmonise all pharmacopoeias including Indian Pharmacopoeia (IP) for effective regulatory compliance and hence drug quality. Industry veterans have for long been advocating that there is a need for adoption of global harmonised standards by Indian excipients industry for patient safety even as the US, Europe and China have taken the lead. International Pharmaceutical Excipients Council, India has therefore set the agenda to harmonise regional guidelines to gradually achieve and adopt global harmonised standards. Industry advocates that the situation in India warrants action as there is no regulation in India apart from monograph on excipients mentioned in IP.

Compliance is the main mantra for regulators: Maharashtra FDA Commissioner

Pharmabiz India - Yash Ved

“Compliance is the main mantra for regulators,” said Dr Pallavi Darade, Commissioner, Food and Drug Administration, Government of Maharashtra. Speaking at a seminar-cum- interactive meeting held in Mumbai recently by the Pharmaceuticals Export Promotion Council of India (Pharmexcil), Dr. Darade added, "We are in discussion with all the stakeholders on environmental clearance issues. We have also taken various measures on no objection certificate (NOC) making decentralised for pharma industry. Pharma exports have done well despite slowdown. We believe that the pharma sector will do well in future also." The meeting was held to disseminate information to member-exporters of Pharmexcil regarding the proactive measures adopted by the government of India in promoting exports, to educate the members regarding the recent major changes in Incoterms, Iran trade business under rupee payment mechanism, etc. Raghuveer Kini, executive director, Pharmexcil added that the seminar was organised basically to inform the members about the steps taken by the government of India for exporters and ease of doing business and also there is lot of scope for trade with Iran in pharma industry. B N Vishwas, joint director general of foreign trade, Mumbai zonal office, said, "Basically, the current Foreign Trade Policy will come to an and end soon. The new scheme will replace Merchandise Exports from India Scheme (MEIS) and EPCG scheme. There are some changes in the new Foreign Trade Policy. The Union commerce ministry will soon formulate a new scheme, Scheme for Remission of Duties and Taxes on Exported Products (RoDTEP), to cover all export sectors under a framework for the refund of all un-refunded taxes or duties/levies, not exempted or rebated at present by any other mechanism.