- Stockouts are being reported across the country of a key patented drug, Delaminid, used in drug-resistant tuberculosis (DR-TB), hampering the government’s goal of TB elimination and causing hardship to patients. Much worse, the procurement of the drug is still pending as negotiations with the Japanese patent holder Otsuka are stuck due to the high price, health activists told TOI. India has the highest burden of DR-TB, accounting for about one-fourth of the global burden. Among them are the most difficult to treat, XDR-TB (extensively drug-resistant TB) cases. Children with DR-TB and adult patients with XDR-TB need inclusion of both the new TB drugs, Otsuka’s Delaminid and Johnson & Johnson’s Bedaquiline to ensure an injection free, less toxic and effective regimen. In the case filed by patient groups in March, the Centre rejected compulsory licensing for the generic supply of Delamanid, citing “available stock is sufficient to meet the requirements for the next nine months.” The situation has become worse since May with shortages reported of essential TB drugs at several DOTS centres across the country, with hotspots like Mumbai and Delhi suffering the most. Stocks are also running thin in states like Karnataka and Uttar Pradesh, a TB activist said.
- In a progressive breakthrough in the Antifungal Therapy domain, Intas Pharmaceuticals has launched the world's first Super Bioavailable Itraconazole-SB 100mg under the Brand Name - Itaspor-SB Forte/Subawin. It has been recently approved by Indian Regulatory Authorities. Conventional Itraconazole mainstay drug to fight fungal infection has high result variance and low patient compliance because of dosing dependence upon food, acidic beverage, antacids consumption etc. and overall cost of treatment. "Itaspor SB Forte/Subawin is expected to improve patient compliance and reduce the Doctor's counselling time. It will reduce dosing to half," the company said in a recent release. Furthermore, patients can take it with or without a meal with just water or as directed by the physician. The cost of the therapy is also reduced substantially.
- Dr. Renu Swarup, Secretary, Department of Biotechnology on October 14, 2021, virtually launched India’s first ‘One Health’ Consortium. The newly launched consortium envisages carrying out the surveillance of important viral, bacterial and parasitic infections of the zoonotic as well as the transboundary pathogens. Dr. Swarup, while speaking on the occasion, informed that the ‘One Health’ Consortium consisting of the 27 organizations led by the DBT- National Institute of Biotechnology, Hyderabad is one of the biggest health programmes that has been launched by the Indian Government in the post-COVID-19 times. ‘One Health’ Consortium consists of AIIMS Jodhpur, AIIMS Delhi, IVRI, Bareilly, GADVASU, Ludhiana, TANUVAS, Chennai, MAFSU, Nagpur, Assam Agricultural and Veterinary University, and many more ICAR, ICMR Centers, and wildlife agencies.
- A two-member bench of the Income-tax Appellate Tribunal (ITAT) in Mumbai has directed that a larger bench should decide whether the expenses on freebies to doctors incurred by pharma companies should be allowed as a business deduction. The fallout of any disallowance of expenditure is that the taxable income goes up, resulting in a higher tax outgo. Typically, pharma companies, large or small, do incur marketing expenses, a significant portion of which constitutes ‘freebies’ to doctors. The ITAT bench observed that the freebies come with strings attached. They cannot be lawfully accepted by medical professionals under the Medical Council Act. Therefore, an expenditure on such freebies is for a purpose prohibited by law. An explanation to Section 37(1) of the I-T Act denies claim of any such expense if the same has been incurred for a purpose which is either an offence or prohibited by law. This explanation was inserted by the Finance Act, 1998 with retrospective effect from April 1, 1962. Thus, the stand of the I-T officer cannot be faulted, the order stated. A circular issued in 2012 by the Central Board of Direct Taxes (CBDT), provides that any expenses incurred by a pharma company in providing ‘freebies’ to doctors in violation of the regulations issued by the Medical Council of India (MCI) will be disallowed in the hands of the company. However, the ITAT bench noted the differing decisions on this issue by the coordinate benches.
- Hyderabad-based pharma player MSN Laboratories Pvt Ltd on Monday said it has rolled out India’s most affordable version of type-2 diabetes drug Empagliflozin (SGLT2i) under the Empaone brand at a price of Rs 15.90 for each 10 mg tablet and Rs 18.90 for each 25 mg tablet. A sodium-glucose co-transporter-2 inhibitor, MSN’s Empaone is a generic version of Boehringer Ingelheim’s Jardiance and is used for the treatment of type-2 diabetes. MSN said it has developed the Active Pharmaceutical Ingredient (API) & the finished dosage formulation (FDF) of Empaone at its in-house R&D center. Hyderabad-based Dr Reddy’s Labs has launched copies of Jardiance, successful anti-diabetes tablet offered by German drug maker Boehringer Ingelheim (BI). The drug has legitimate patent in India till 2025 and consultants say the launch is prone to take a controversial spin and head for a courtroom battle. BI could search non permanent restraining order and declare damages for patent infringement. Gross sales of Jardiance stood at roughly ?250 crore until August this yr, based mostly on the 12-month shifting annual whole (MAT), in line with IQVIA, a worldwide knowledge science and pharma consulting agency. Beneath its model Vicra, Dr. Reddy’s is predicted to promote the drug in India at lower than a 3rd of the value charged by Boehringer Ingelheim. In response to sources the ten mg variant of Dr. Reddy’s model could value ?15 per pill in opposition to ?51 of the innovator’s model. For the 25 mg variant, the value will probably be ?18 per pill in opposition to ?62 of BI’s drug. On-line pharmacy 1mg exhibits Jardiance is offered at a 25% value low cost. The choice of Dr. Reddy’s stunned many within the business since this would be the first occasion that the corporate has launched copies of a model with a sound patent.
- References: ETHealthworld, TOI, Medical Dialogues, News nation?
