NPPA extends trade margin capping on five medical devices till July, 2022

The National Pharmaceutical Pricing Authority (NPPA) has extended the timeline for the trade margin capping of the five medical devices which are essential during the Covid-19 pandemic period till July 31, 2022.

The Authority has issued an order that the capping on the trade margin of the five medical devices – pulse oximeter, blood pressure monitoring machine, nebuliser, digital thermometer and glucometer – at 70 per cent at first point of sale, to be extended from the earlier period ending January 31, 2022, to July 31, 2022.

NPPA initiated the margin capping through a notification in July 13, 2021, under the Drugs (Price Control) Order, 2013, at the first point of sale of these products through Trade Margin Rationalisation (TMR) approach. The related notes issued with the order in July, shall remain in force during the currency of the new order, it added.

The notification mandated to fix the Maximum Retail Price (MRP) as per the specified formula: “Maximum Retail Price = Price to Distributor (PTD) + (PTD x TM) + Applicable GST, Where TM = Trade Margin not exceeding 70%.”

NPPA, through an office memorandum on July 14, also directed manufacturers and importers of these medical devices to submit revised MRPs of their products, in pursuance to the price capping. Based on the data provided, the downward revision of MRP was reported by imported and domestic brands across all the categories.
Following this, a total of 1,132 products, including 277 pulse oximeters, 329 blood pressure monitoring machines, 105 glucometers, 164 digital thermometers and 257 nebulisers have reported prices of which 1,033 (91%) reported downward revision of MRP. The decrease in MRP was between Rs.12 to Rs. 2,95,375 (1%-89%) for pulse oximeters, Rs. 20 to Rs. 38,776 (1%-83%) for blood pressure monitoring machine, Rs. 30 to Rs. 2,250 (1%-98%) for glucometer, Rs. 8 to Rs. 44,775 (1%-89%) for digital thermometer and Rs. 56 o Rs. 6,165 (1%-83%) for nebuliser, according to NPPA.

The price regulator, through a notification on March 31, 2020 has brought that all medical devices including pulse oximeter, blood pressure monitoring machine, nebuliser, digital thermometer, and glucometer, to be governed under the provisions of DPCO, 2013 with effect from April 1, 2020.

It may be noted that earlier, the Authority has also extended the capping of trade margin of oxygen concentrators at the first point of sale for fixation of maximum retail price from November 30, 2021 to May 31, 2022.

The move resulted in price reduction of 70 out of 252 products and the MRP was reduced up to 54% (up to Rs. 54,337). The pricing of oxygen concentrators did not adversely impact domestic production and no disruption in supplies were observed, said NPPA officials.

Source : Pharmabiz

Budget 2022 stops pharma companies from claiming tax cuts on freebies to doctors

Mankind Pharma signs agreement to buy Panacea Biotec Pharma’s domestic biz

Mankind Pharma entered into an agreement to buy the domestic formulations business of Panacea Biotec Pharma, a subsidiary of Sputnik V maker Panacea Biotec for Rs 1,908 crore.

In a notification to the stock exchanges on Tuesday, Panacea Biotec said that its board approved the decision to sell the domestic formulations business including formulations brands in India and Nepal, related trademarks, copyrights etc of its subsidiary Panacea Biotec Pharma to Mankind Pharma for Rs 1908 crore (exclusive of taxes). Panacea Biotec Pharma and Mankind Pharma entered into a binding term sheet on January 31.

The stocks of Panacea Biotec were up 5 percent on the BSE at the end of day’s trade.

According to reports, Panacea Biotec Pharma was struggling to repay debt and Piramal Enterprises and India Resurgence Fund (IndiaRF) had extended the repayment date last year.

Both Rajesh Jain, MD Panacea Biotec and RC Juneja, chairman of Mankind Pharma could not be reached for an immediate comment.

The domestic business assets generated a turnover of Rs 219.85 crore in the last financial year, which was 63.75 percent of the total revenue of Panacea Biotec Pharma, and around 35 percent of the consolidated turnover of Panacea Biotec.

Panacea Biotec or the parent company had transferred its pharma formulations business, formulations facility at Baddi, related R&D and natural products extraction activities at Lalru to its wholly owned subsidiary Panacea Biotec Pharma in 2020.

Serum Institute of India CEO Adar Poonawalla holds an 8.59 percent stake in Panacea Biotec, which makes vaccines and pharmaceutical products.

Source : Business Standard

Health ministry amends Drug Rules to include liquid antiseptic under Schedule K

The Union health ministry has issued a final amendment to include liquid antiseptics for household use under the Schedule K of Drugs Rules, 1945 exempting the product category from the requirement of sale license.

Through the notification, liquid antiseptics for household use have been added as the 39th entry in Schedule K under the Drugs Rules, 1945. The exemption is from the provisions mandating sale licenses in Form 20 or Form 20A, which is expected to make the use of liquid antiseptics more accessible to the consumer.

A draft amendment was issued in this regard in September, 2021, after the Drugs Technical Advisory Board (DTAB), in June recommended the exemption of these products from sales licensing through including them in the Schedule K of drugs Rules.

The liquid antiseptics from companies including Reckitt Benckiser and ITC have been in high demand in the market after the outbreak of Covid-19 pandemic.

However, even before this, the Drugs Consultative Committee (DCC) in 2019 set up a sub-committee to decide on whether the liquid antiseptic in the market should be regulated with a sale license or brought under the Schedule K of the Rules.

The DCC in its 55th meeting held on January 31 and February 1, 2019, has constituted a sub-committee for clarification on exemption of Dettol antiseptic liquid (cloroxylenol, terpineol and alcohol) as antiseptic and disinfectant in the country under Schedule K (Rule 123) of Drugs and Cosmetics Rules 1945 and identify such similar type of products and give its recommendations.

The sub-committee was constituted under the chairmanship of N K Ahooja, Drugs Controller, Haryana. As per the terms of reference, the Sub-committee in its meeting held on July 26, 2019 invited the representatives from Reckitt Benckiser, manufacturer of Dettol antiseptic liquid and ITC Limited, manufacturer of Savlon antiseptic liquid, both leading manufacturers for antiseptic liquids to offer their views.

After consideration of the available technical and legal information and detailed deliberations the sub-committee submitted its report for DCC review and deliberations. The DCC, after detailed deliberation, observed that there are numerous such products in the market which the sub-committee did not evaluate due to its specific mandate on three products only. Hence DCC suggested that the scope of the sub-committee shall be revised and broadened to relook the matter for examination of all the available liquid antiseptic solutions in the market.

Later, the matter came up for the approval of DTAB and it has recommended the inclusion of the product category under Schedule K for exemption. The drugs specified in Schedule K are exempted from the provisions of Chapter IV of the Act and Rules to the extent and subject to the conditions specified in that Schedule.

The draft notification was issued on September 13, inviting objections and suggestions from the stakeholders, and the objections and suggestions received from the unlicensed has been considered by the Central government, said the final notification.

Source : Pharmabiz

Commerce ministry begins anti-dumping probe against ursodeoxycholic acid imported from China & South Korea

The Union commerce ministry has initiated anti-dumping probe against ursodeoxycholic acid, a chemical used in drug industry, imported from China and South Korea, following a complaint filed by Arch Pharma Labs.

Ursodeoxycholic acid is also known as Ursodiol or UDCA. It is used as medical therapy in gallstone disease (cholelithiasis) and for biliary sludge. It may be given after bariatric surgery to prevent cholelithiasis. UDCA is also used as a therapy in primary biliary cholangitis where it can produce an improvement in biomarkers. It is also used to treat primary sclerosing cholangitis. Intrahepatic cholestasis of pregnancy, bile reflux gastritis etc.

The probe is being conducted by the ministry’s investigation arm Directorate General of Trade Remedies (DGTR).

The domestic company Arch Pharma Labs has filed an application before the DGTR seeking an anti-dumping probe concerning imports of UDCA from China and South Korea.

The applicant alleged that the dumping of the chemical has affected the domestic industry.

The applicant is the major producer of UDCA (more than 95 per cent) in India. Another producer is IOL Chemicals and Pharmaceuticals Ltd.

The applicant claimed that its performance has been severely impacted in the form of low production, sales and market share and significant losses, cash losses and negative return on capital employed.

On the basis of the duly substantiated written application by or on behalf of the domestic industry, and having satisfied itself, on the basis of the prima facie evidence submitted about the dumping, the DGTR has initiated the investigations, according to a notification of the directorate.

The proposed period of investigation is from October 2020 to September 2021. The injury investigation period for the present investigation will be 2018-2021 and period of investigation.

If it is established that the dumping has caused material injury to the domestic players, the DGTR would recommend the imposition of anti-dumping duty on imports from China.

The finance ministry takes the final decision to impose the duties.

Countries conduct anti-dumping investigations to determine whether their domestic industries have been hurt because of a surge in cheap imports. As a countermeasure, they impose these duties under the multilateral regime of the Geneva-based World Trade Organisation (WTO).

The duty is aimed at ensuring fair trading practices and creating a level-playing field for domestic producers vis-a-vis foreign producers and exporters. India has already imposed an anti-dumping duty on several products to cope up with cheap imports from various countries, including China.

Source : Pharmabiz

Scientists Find Cure For Diabetic Foot Ulcers

People with diabetes, often struggle with diabetic foot ulcers, but not anymore. A team of scientists from the Banaras Hindu University (BHU) have found a cure. The findings of the study were published in the National Centre for Biotechnology Information, National Institutes of Health, US. The team led by Prof Gopal Nath of the department of Microbiology, Institute of Medical Sciences, said that wounds that took months and years to heal, could now be cured in days or months.

Prof Nath said that a wound is defined as a breach in the skin or body tissues due to injury. An acute wound is defined as a “recent break that is yet to progress through sequential stages of healing”.

The wounds where the normal healing process is stalled due to underlying pathology (vascular and diabetes) or infection beyond three months is defined as a chronic wound. While chronic wounds always get infected, the contaminated wounds are reasonably susceptible to infection.

Infection with antibiotic-resistant bacteria and biofilm formation halt healing progress. These wounds cause significant psychological and physical morbidity.

The traditional treatment strategies often succeed in healing wounds, he said adding that many wounds have been observed recalcitrant to them, leading to persistence and recurrent infections. Search for alternatives to antibiotics has now become a compulsion.

Fortunately, bacteriophage therapy is a re-emerging solution to antibiotic-resistant bacteria. Prof Nath’s team carried out phage therapy of acute and chronic infected wounds in animals and clinical studies. It showed efficacy against Pseudomonas aeruginosa in a mice wound model. Furthermore, they evaluated the efficacy of phage cocktails in animal models’ acute and chronic osteomyelitis caused by methicillin-resistant Staphylococcus aureus.

They also observed biofilm eradication from K wire in rabbits’ wound infection model.

Clinical trials of phage therapy initiated by the BHU have reported the efficacy of topical phage in healing chronic wounds in three prospective exploratory studies and no adverse events mimicking the results in vivo animal models.

A clinical study by Gupta demonstrated the significant role of bacteriophage therapy in the chronic wounds associated with antibiotic-resistant bacteria.

The study employed a total of twenty patients with chronic non-healing ulcers for more than six weeks duration. A significant improvement could be achieved in the form of complete wound epithelization within a few weeks.

Another study, employing 48 patients having a minimum of one eligible full-thickness wound that did not heal in six weeks with convention wound management, showed the promising result, and significant improvement was observed in the wound healing.

The study projected that specific phage therapy is equally effective regardless of the diabetic or non-diabetic status of the patient though the healing was relatively delayed in diabetic patients.

Another successful study has shown encouraging results on healing process of infected acute traumatic wounds.

The average number of days required for complete granulation of wounds and attaining sterility and healing was half compared to conventional therapy.

Source : India.com

Central govt to study drug pricing in 10 countries to make medicines affordable in India

To make drugs accessible and affordable in India, the Narendra Modi government is set to kickstart a study on drug pricing policies of at least 10 countries, including China, Sri Lanka, Bangladesh and the United States, News18.com has learned. The department of pharmaceuticals (DoP) – under the union ministry of chemicals and fertilizers – has rolled out a tender in search of a reputed company that can conduct the study on behalf of the government.

The objective of the research is to understand the drug pricing methodology adopted in the international market covering at least 10 countries. It also aims to understand the lessons learned or the best practices from various countries (or regions) in terms of the availability and affordability of medicine.

NPPA at the helm

According to the request for proposal (RFP) document labelled ‘Notice Inviting Tenders’, accessed by News18.com, drug pricing watchdog National Pharmaceuticals Pricing Authority (NPPA) desires to engage reputed firms or research institutions for conducting a study. NPPA is an arm of the DoP.

The title of the document reads “To study the drug pricing policies of different countries/ regions and lessons learned from these countries/ regions in terms of access to medicine at affordable prices”.

The deadline to submit the proposal is February 21, the document states, while shortlisted bidders will be called for presentation on 1 March.

Study will involve secondary sources, top 10 countries selected

The government, according to the document, plans to study regulatory policy or framework on drug pricing of at least 10 countries (or regions), to identify best practices or lessons learned. It also plans to study the operational implementation of the drug pricing policies in different countries apart from studying other policy aspects that impact the availability and affordability of medicine in these countries.

“The minimum ten countries/regions that should be covered are Sri Lanka, Bangladesh, China, EU, UK, Australia, USA, Brazil, South Africa, and Thailand,” the document states.

The study will primarily be based on secondary sources of data and other information available in public domain. It also involves interviews or focuses group discussions (FGDs) with foreign missions, relevant trade and industry associations, drug exporters, foreign manufacturers to elicit their feedback or views.

According to the 18-page RFP document, the final report after the selection of the firm has to be submitted in four months. “Besides this, quarterly progress shall be submitted by the applicant till the final submission of the report,” it says.

Source : First Post

SIT Raids 16 Medical Shops At Srivilliputhur In South Tamil Nadu

Tightening the noose around medical shops who sell medicines without valid prescriptions, a surprise raid was conducted in 16 medical shops in Srivilliputhur in Viruthunagar district in southern Tamil Nadu by the Special Investigation Team (SIT) formed by the director of the state drugs control department.

The director was acting on a tip-off he received two days ago. Followed by it he constituted a special team of officials without involving officers from the local area, and conducted the raid in all the medical shops in the small town. Officials from the department said the directorate is taking legal action against the license holders for contravention of provisions of sale licences.

The raid team did not confiscate any medicine from the shops, but seized bill books, prescription register and other documents. However, not any NSQ or date expired or spurious or substandard drug was found in the raid in any of the shops, but violation of provisions of Rule 65 (9) (a) of the drug act was galore.

Briefing Pharmabiz, S Sivabalan, the director of drugs control administration, said the department got the information about the contravention last week and it was found that violation of Rule 65 was spiralling in the southern districts of the state for the last two years because of Covid pandemic and the lockdown. He said most of the medicines the retailers were selling in Srivilliputhur through their shops were habit forming drugs. The department will take legal action against the pharmacies as per the Indian Drug Act and the Rules.

When Covid-19 was announced in March 2020 the directorate of drugs control administration became more vigilant and swung into action. All the drug inspectors and ADC offices were given strict instruction to conduct raids in all medical shops and report to the head office. The initiative was to restrain people from indulging in self-medication during the pandemic period as people with mild and moderate symptoms of Covid-19 and even asymptomatic were going to the medical shops asking for scheduled category drugs along with paracetamol. Further, all the retail pharmacies were informed not to sell any prescription drug along with OTC products. However, several medical shops in many areas violated the direction of the department and sold scheduled category drugs without doctors’ prescriptions. Finding contravention of rules, the department formed special squads and conducted raids various times and initiated actions.

In May and June last year, in a statewide raid, the sleuths of the drugs control department initiated legal action against 85 medical shops for breach of Rule 65. At that time most of the cases were registered against the medical shops for selling ivermectin, azithormycin, doxycycline, amoxicillin and other antibiotics along with paracetamol tablets.

In October 2021, following information from the intelligence wing of the department a special squad was formed by the director and conducted surprise raids in Theni district and initiated action against selling drugs without prescription. An officer close to the DC department in Chidambaram said a surprise raid is being planned by the SIT to be conducted in Salem and Erode probably next week.

Some health action groups informed Pharmabiz that the department sleuths are not conducting any raid in the border district of Coimbatore where some wholesalers and retailers are collecting large quantities of medicine supplies from Karnataka and Kerala.

Source : Pharma Biz

Health ministry updates discharge policy for mild to moderate COVID-19 cases

The Union Ministry of Health and Family Welfare has updated the discharge policy for mild to moderate cases of the novel coronavirus disease (COVID-19) in its latest briefing.

The former can be discharged seven days after testing positive, followed by three consecutive days of no fever. There is no need to conduct an RT-PCR test at this stage.

For the latter group, there must be a complete resolution of symptoms with oxygen saturation above 93 per cent — without any support — for three consecutive days for them to be discharged.

The decision was arrived upon after a review meeting with Prime Minister Narendra Modi earlier this week.

The briefing took place on a day when India recorded 194,720 new COVID-19 cases and 422 deaths in the past 24 hours. This has taken the total active caseload up to 955,319 — the highest in over 200 days — and total deaths to 484,655.

The positivity rate stands at 11 per cent for the entire country. Maharashtra (22.39 per cent), West Bengal (32.18 per cent), Delhi (23.1 per cent) and Uttar Pradesh (4.47 per cent) are the states of most concern.

Tamil Nadu, Karnataka, Kerala and Gujarat are other emerging states of concern. More than 300 districts are currently reporting a positivity rate greater than 5 per cent — the benchmark which once crossed, becomes a cause of concern, according to the World Health Organization.

“Omicron is not the common cold. It is our responsibility to slow it down. Let us mask up and get vaccinated, whoever is due. It is a fact they (vaccines) are helpful to an extent. Vaccination is a critical pillar of our COVID-19 response,” Niti Aayog Member (Health) VK Paul said.

India has fully vaccinated 46 per cent of its total population as of now. The drive for children aged between 15 and 18 years began January 3, 2022, in which more than 20 million doses have been administered.

The booster dose drive for healthcare workers and those above 60 years of age with comorbidities began January 10. The booster shot will be the same as the vaccine used for primary doses according to the Indian Council of Medical Research (ICMR).

There have also been growing concerns about the misuse of COVID-10 therapeutics.

“There should be a rational approach for medicine use. We are concerned about the overuse and misuse of drugs. Do not overuse it, it will have an aftermath … Have warm water, do gargles at home,” Paul said.

Molnupiravir, an antiviral developed by Merck & Co, Inc, is the most talked about in India currently.

The Drugs Controller General of India (DCGI) has approved it for Emergency Use Authorisation. But it has not been included in the national COVID-19 treatment protocol, given its severe side effects.

Monoclonal antibodies are another such therapeutic. No antibody cocktail that is effective against the omicron variant, is available in India at the moment.

The upcoming elections in Punjab and Uttar Pradesh are also a worry. The Election Commission (EC) has banned any rally till January 15. But it remains to be seen what will happen after that.

“The Election Commission has issued guidelines related to gatherings and rallies. As the situation evolves, we will coordinate with the EC. A decision will be taken accordingly,” the health ministry noted.

Mansukh Mandaviya, Union health minister, chaired a meeting with a number of officials in Chennai January 12 to take stock of the COVID-19 situation.

These included the regional director of Directorate General of Health Services, officers from the National Centre for Disease Control, deputy director of DCGI, regional head of ICMR and the Food Safety and Standards Authority of India.

Source : Down To Earth

Do not give Paracetamol to teens after Covaxin Shot, Says Bharat Biotech

New Delhi: Bharat Biotech on Wednesday said no painkillers or paracetamol are recommended after being vaccinated with its COVID-19 vaccine Covaxin.

Stating that it has received feedback that certain immunisation centres are recommending taking three paracetamol 500mg tablets along with Covaxin for children, the company clarified that such a step was not required.

“No paracetamol or painkillers are recommended after being vaccinated with Covaxin,” Bharat Biotech said in a tweet.

Paracetamol was recommended along with certain other COVID-19 vaccines and is not recommended for Covaxin, it asserted.

“Through our clinical trials spanning 30,000 individuals, approximately 10-20 per cent individuals report side effects. Most of these are mild, resolve within 1-2 days, and do not require medication. Medication is only recommended only after you consult a physician,” the company said.

Last month, the Drugs Controller General of India (DCGI) had granted emergency use authorisation to indigenously-developed Bharat Biotech’s Covaxin for children above 12 years with certain conditions.

Prime Minister Narendra Modi had announced that vaccination against COVID-19 for children between 15-18 years would start from January 3.

Subsequently, India opened up vaccination for the 15-18 years age-group on Monday and so far over 85 lakh beneficiaries in the category have received the first shot.

Source NDTV