News Analysis India

Tag: Tocilizumab

  • ‘Will antibody cocktail of Roche reduce demand for Tocilizumab?’ HC asks Centre

    By PTI
    NEW DELHI: The Delhi High Court has asked the Centre whether demand for COVID-19 drug Tocilizumab, which is in short supply, would be reduced if drug major Roche provides its new antibody cocktail that has been approved for emergency use in India for coronavirus patients.

    The court also asked the Centre what quantities of the antibody cocktail would be required for the purpose of reducing demand for Tocilizumab.

    The query was posed to the government by Justice Prathiba M Singh after Roche India, which supplies Tocilizumab in India, told the court it can only endeavour to supply the medicine and cannot assure to meet the market demand for the same, even though patients are willing to pay for it.

    The court noted that the global manufacturing figures of the drug have not been filed before it by Roche despite specific directions.

    Another reason given by Roche for not being able to supply Tocilizumab was that the antibody cocktail of Casirivimab and lmdevimab medicines “may be a better treatment for COVID-19 patients”.

    The drug major told the court that its “current focus” was to supply the said antibody cocktail and 1,00,000 doses of the same is likely to be sent to India by the end of May.

    As Roche was unable to give any assurance regarding supply of Tocilizumab and since it was required by patients here, the court asked the Centre how it intended to obtain the medicine through the drug major or its global manufacturers, FHoffman-La Roche Ltd in Switzerland and Chugai Seiyaku Kabushki Kaisha in Japan.

    The court also asked the government when the results for the phase III trials of Tocilizumab, approved in favour of two Indian companies – Hetero Biopharma Ltd., and JSS Medical Research India Pvt.Ltd — was expected and what were the applicable guidelines.

    It asked the Centre to file an affidavit answering the queries two days before the next date of hearing on May 27.

    During the hearing on May 12, Roche told the court that a consignment of 45,000 Tocilizumab 80 mg vials, which would cater to around 9000 patients, arrived in India last week in the form of humanitarian aid extended by it.

    Besides that 1,00,000 vials of Tocilizumab 80 mg, to cater to 20,000 doses, had also been imported by Roche India, prior to the stipulated date of May 15 and the same was scheduled to reach its distributor Cipla Ltd, the drug major told the court.

    Cipla, represented by advocate Archana Sahadeva, told the court that according the Clinical Guidelines for the management of Adult COVID-19 patient protocol issued by the ICMR on April 22, Remdesivir, Tocilizumab and convalescent plasma are the three drugs which can be used on an off label basis for the treatment/ management of COVID-19 patients, in certain specific circumstances.

    The ICMR could consider revising the said guidance protocols, in case of presence of an alternative for the said drugs, if required, she said.

    The Centre’s standing counsel Anurag Ahluwalia told the court that sufficient orders, which reflect the demand of Tocilizumab 400 mg, have been placed with Roche India.

    However, the company has been unable to supply the same.

    He said the Centre was following up with Roche India through various channels and is coordinating with them, in order to increase the quantum of imports to India.

    The court was hearing a plea moved on behalf of two COVID-19 patients who were prescribed Tocilizumab by doctors but were unable to immediately arrange the medicine from anywhere.

    They later received the required medication and are stable, their lawyer informed the court on Thursday.

  • Govt hospital staff among three held for black marketing Tocilizumab injections in Faridabad

    By PTI
    NEW DELHI: Three men, including a staff of a government hospital in Faridabad, have been arrested for allegedly black-marketing Tocilizumab injections, used in the treatment of COVID patients, police said on Saturday.

    The accused have been identified as Utkrisht Gupta (22), a resident of Vaishali in Ghaziabad, Manish (32), a resident of Laxmi Nagar, and Raghubir (27), a resident of Faridabad, they said.

    On Friday, police received information that a man was selling Tocilizumab injection at an exorbitant price.

    A client posing as a buyer then called the man who agreed to sell one vial of the injection at Rs 2.90 lakh, a senior police officer said.

    The man asked the customer to come to Laxmi Nagar to get the vial, police said.

    “Police laid a trap at Laxmi Nagar and nabbed Gupta on Friday night. One vial of Tocilizumab injection and one mobile phone was recovered from his possession,” Deputy Commissioner of Police (southeast) R P Meena said.

    Police also searched Gupta’s residence in Sakarpur and recovered another vial of the injection. Gupta disclosed that he had received the vial from Manish, the DCP said.

    Thereafter, Manish was also apprehended from Laxmi Nagar.

    Manish told the police that he had got the vial from Raghuvir who is staff at ESI Hospital in Faridabad, Meena said.

    A trap was then laid at the hospital and when Raghubir came to deliver another vial of Tocilizumab injection to Manish at Rs 1.60 lakh, he was arrested, he said.

    He used to steal the vials from the hospital and sell them to Manish, they said.

    Manish used to supply those injections to Gupta who further sold them in the black market, police said, adding three vials of Tocilizumab injections, one motorcycle and one scooter were recovered from his possession.

  • HC asks Centre to hold meeting with Roche to ensure immediate supply of Tocilizumab

    By PTI
    NEW DELHI: In view of the “acute shortage” of Tocilizumab which is prescribed to a large number of COVID-19 patients, the Delhi High Court has directed the Union Health Ministry and Department of Pharmaceuticals to hold a meeting with Roche India, which sells the drug here, to esnure immediate supplies of the medicine.

    Justice Prathiba M Singh said the officials of the ministry and the department shall hold a meeting with representatives of Roche India and its distributors here “to communicate and assess the demand for this drug in India”.

    “They shall also discuss the modalities for import and supply of the drug as per the expected demand and further logistics for placing orders for the same,” the court said in its May 6 order.

    It passed the order after Roche told the court that it has no confirmed orders from the central government and was not aware of the actual demand in India.

    The court said the minutes of the meeting, to be held on Friday afternoon, shall be placed before it by May 9 evening.

    The court also directed central government standing counsel Anurag Ahluwalia, appearing for the ministry, to obtain instructions from the Office of the Controller General of Patents and place on record the documents relating to the patents that have been granted, if any, in relation to Tocilizumab along with the working statements filed in respect of the said patents.

    A direction was also issued to Roche to file an affidavit confirming that it would be importing in India 50,000 and 25,000 vials of the medicine in mid-May and mid-June, respectively.

    On this aspect Roche said that its distributor/licensee — Cipla Ltd — would have better information regarding distribution and supplies and urged that it too be made a party in the matter.

    The court allowed the request and made Cipla also a party in the matter and listed it for hearing on May 10.

    The court was hearing a plea moved on behalf of two COVID-19 patients who were prescribed Tocilizumab by the doctors, but were unable to arrange the medicine from anywhere.

    One of the patients, who moved the plea on May 5, was provided the medicine after the court intervened and in respect of the second, who approached the court on May 6, the lawyers for the Centre and Delhi government said they will make efforts to make the required dose available to her.

    During the hearing on May 6, Roche told the court that the drug was not being manufactured in India and the sudden spurt in its demand was unexpected.

    It said that in 2019, the demand for total consumption was only about 8,900 vials for the entire year.

    However, from March 2020 to April 2021, a total of 2,10,000 vials have been supplied to India.

    “The latest batch of vials imported was of 11,000 vials on April 26, 2021. Out of the said batch, 9,900 vials were supplied to the central government for distribution to COVID-19 related institutions, and 1,100 vials were supplied to other government institutions for being administered to patients suffering from arthritis,” the company told the court.

    It further told the court that an emergency approval has been obtained for an ‘Antibody Cocktail Treatment’ which would be distributed in India, and this would be a treatment meant specifically for COVID-19, unlike Tocilizumab which was originally a drug for arthritis and is only an investigational therapy for COVID-19.

    Ahluwalia told the court that the central government does not have any stock of the drug with it as what it received was distributed to the states, union territories and other institutions.

    Delhi government told the court that the entire stock of 500 vials of the drug which was received by it has already been distributed and there is no stock available with it.

    It also told the court that it does not collect data relating to consumption of Tocilizumab from the hospitals or medical establishments to whom the vials were supplied.

  • Plea in SC for GST exemption on COVID-19 related drugs, medical equipment

    By PTI
    NEW DELHI: A plea has been filed in the Supreme Court seeking GST exemption for Remdesivir, Tocilizumab, Favipiravir and other COVID-19 related drugs with similar generic constitution as well as medical equipment.

    The intervention application has been filed by an NGO, ‘Public Policy Advocates’, in the pending suo motu case by the apex court on distribution of essential supplies and services during pandemic.

    The application sought direction to the Centre to issue appropriate ad-hoc guidelines, orders or notifications “exempting COVID-19 related drugs including but not limited to Remdesivir, Tocilizumab, Favipiravir and other drugs with similar generic constitution, medical equipment including but not limited to Ventilators and Bipap Machines, and other medical treatment.”

    It also sought direction to Goods and Services Tax (GST) council secretariat to convene a meeting expeditiously and direct exemption of GST with immediate effect on COVID related drugs and medical equipment which also include ventilators, medical grade oxygen and oxygen concentrators.

    “That as the country grapples with an acute and devastating surge in cases with the second wave, an overnight demand for the aforesaid drugs and necessary medical equipment has exponentially increased manifold”, the plea said.

    The NGO sought exemption of COVID-19 related drugs, medical equipment, other medical treatment for infection prevention, control measures and supportive care for patients from GST in accordance with provisions of the Central Goods and Services Tax Act, of the Integrated Goods and Services Tax Act, 2017 and the corresponding equivalent sections in the State legislations.

    “Giving the figures, it said that in 63 days cases have risen from 8,000 on February 2, 2021 to 1, 03,558 as of April 5, 2021 and in one day alone on April 26, over 3. 2 lakhs cases of COVID-19 were reported and the number of deaths crossed over 2,000 over a period of seven days as per the official data released by the Government.”

    “The number of infected persons in the country was estimated at 3.8 lakhs and numbers of deaths are reported to be about 3,645 as on April 28, 2021, being the highest single day rise in the number of COVID-19 positive cases and number of deaths recorded in India,” the plea added.

    It said that the increase in cases brings with itself the inevitable financial burden on the families of the patients coupled with inadequate and intermittent supply of such medical drugs and equipment which are deemed crucial for the purposes of treatment for COVID-19.

    The plea said that section 11 of CGST Act confers the power of exemption from payment of GST on goods and services to the Goods and Services Tax Council (GST Council).

      It added that the All India Institute of Medical Sciences (AIIMS) and Indian Council for Medical Research (ICMR) have established a National Task Force and Joint Monitoring Group in view of the severe spiralling up of cases of COVID patients, and have identified three categories of patients who are afflicted with COVID-19.

    “These three categories are identified as mild, moderate and severe disease as per Clinical Guidance of Adult COVID-19 patients dated April 21, 2021. According to these guidelines, cases of moderate and severe diseases require urgent hospitalization and have to be administered drugs to counteract the various adverse physiological effects caused by the Coronavirus,” it said.

    It said that in both moderate and severe categories of cases and in specific circumstances, the use of Remdesivir, Tocilizumab, and Methylprednisolone have been prescribed by the National Task Force.

    “It is clear that the Act empowers the Central Government to exempt goods or services, or both, from the tax leviable thereon on the basis of the recommendations of the Goods and Services Tax Council/Respondent No.2 if it is satisfied that it is necessary in the public interest”, it said.

    The plea said the pandemic is a textbook situation when exercise of the power of exemption is a public necessity as part of the commitment of the welfare state to raise the standards of public health, as part of its commitment in the Directive Principles of State Policy, and to preserve and protect the right to life of countless citizens who are suffering from moderate and severe COVID infections.

    It said that the 42nd GST Council Meeting was held on October 5, 2020, that is after the use of an antiviral drug named Remdesivir was found to be a part of the uniformly acceptable part of treatment protocol.

    “However, there have been no recommendations with respect to exemption of GST leviable on such drugs and their equivalent generic variants and medical grade oxygen,” it said, adding that an exemption of 12 percent cost of the product charged as GST which is otherwise leviable, would lead to a further decrease in the overall cost of the product, thereby making it significantly more affordable to the common public which is in dire need of this critical drug.

  • Haryana government issues directions for restricted sale of Remdesivir, Tocilizumab

    By PTI
    CHANDIGARH: Haryana’s Food and Drugs Administration Department on Wednesday issued directions for restricted sale and distribution of drugs like Remdesivir and Tocilizumab used to treat patients with severe COVID-19 symptoms in a bid to stop its irrational use.

    A department spokesperson said that keeping in view the emergency and unmet medical need for COVID-19 disease, the Central Drugs Standard Control Organization (CDSCO) had approved restricted emergency use of Remdesivir injectable formulations for treatment of patients with severe COVID-19 infection.

    He said the government has also issued directions that Remdesivir formulations are required to be sold under the prescription of medical specialists only.

    Further, Remdesivir formulations are required to be supplied for use only to the hospital/institutions to ensure proper use of the drugs as recommended, he said in a statement.

    The spokesperson said it has come to the notice of the department that some doctors are irrationally prescribing the Remdesivir injection, which is approved as an emergency drug by Drugs Controller General of India and to be used only for coronavirus patients in ICU beds/ventilator.

    “Therefore, it should not be prescribed by doctors for patients not admitted in hospitals or home isolated patients, having no ICU/ventilators and not prescribed for conditions for which these drugs are not approved,” he said.

    The spokesperson said all the sellers of these drugs have been directed to send the details of all purchases and distributions to the State Drugs Controller, Haryana in the office of Commissioner, Food and Drugs Administration, Panchkula.

    Besides, they have been directed to restrict sales to dedicated COVID-19 hospitals only, which have ICU beds and critical care facility provided for management of such patients.

    The spokesperson further said any unauthorised sale of Remdesivir or Tocilizumab is punishable under the Drugs and Cosmetics Act for which drug licenses may be suspended or cancelled.

    Besides, any black marketing/hoarding of these drugs are cognisable and punishable offences for which stringent action of registration of FIR will be taken.

  • Govt makes interim allocation of COVID-19 treatment drug Tocilizumab to states

    By PTI
    NEW DELHI: The Union government has made an interim allocation of Tocilizumab among the states, as a fresh limited stock of the drug used for the treatment of COVID-19 patients has arrived in the country.

    In a letter, Pharma Joint Secretary Navdeep Rinwa and Health and Family Welfare Ministry Director Rajiv Wadhawan said the drug went out of stock in the country a few weeks ago due to a sudden surge in its demand because of a sharp rise in COVID-19 cases in the country.

    Fresh limited stock of this drug has now been imported and is available with lone marketer company Cipla Ltd for marketing and distribution in the country, the letter said.

    “An interim allocation of this drug among states has been finalised by MoHFW (Ministry of Health and Family Welfare) and the DoP (Department of Pharmaceuticals) in consultation with the company,” it added.

    The allocated stocks have been sent and are being sent to the Cipla depots in the respective states and are “placed at the disposal of the states for the allocation to the government and private hospitals in the state”, the letter said.

    No separate allocation is being sent to private hospitals, it added.

    “The states are advised to ensure that these limited stocks are used judiciously and strictly as per the standard treatment protocol issued by the Joint Monitoring Group of MoHFW,” the letter said.

    The company has been directed to issue the allocated stocks strictly as per the guidance of the state governments concerned.

    “The allocation is interim and would be reviewed shortly,” it added.

    The letter was sent on Tuesday (April 27) to the chief secretary/ principal secretary and secretary health of the states and Union Territories that have been alloted the drug.

    According to the letter, the interim allocation of tocilizumab is to states including Andhra Pradesh, Bihar, Chhattisgarh, Delhi, Gujarat, Haryana, Jharkhand, Karnataka and Kerala.

    The allocation is also for Madhya Pradesh, Maharashtra, Odisha, Punjab and Chandigarh, Rajasthan, Tamil Nadu, Telangana, Uttar Pradesh, Uttarakhand and central institutions.

    India saw a record single-day rise of 3,60,960 coronavirus cases, which pushed the total tally to 1,79,97,267, while the death toll crossed two lakh following 3,293 fresh fatalities, according to Union health ministry data updated on Wednesday.

  • COVID-19: Indore oxygen firms told to supply to hospitals only; MP’s positivity rate nears 11 per cent

    By PTI
    INDORE: The Indore administration on Monday asked local oxygen manufacturers to stop production of industrial grade oxygen and supply the gas only for medical use to treat serious COVID-19 patients.

    The administration issued an order in this regard in view of the rising cases of COVID-19 in Indore, Madhya Pradeshs worst coronavirus-hit district.

    Besides, it regulated the sale and purchase of Remdesivir and Tocilizumab, the key injections used in treatment of COVID-19 patients.

    Indore District Magistrate Manish Singh issued the order on medical oxygen supply and the two drugs under the Disaster Management Act 2005 and the Epidemic Diseases Act 1897.

    Oxygen manufacturing factories located in Indore district limits will be covered by the order.

    According to Additional Chief Secretary (Health) Mohammed Suleman, 61 per cent of COVID-19 patients are being treated at home, while the rest (39 per cent) are admitted in hospitals in the state.

    Of the hospitalised patients, 27 per cent were on oxygen support, he told reporters in Bhopal.

    According to the order, it was mandatory for purchasers of the two injections to produce the patient’s identity proof, coronavirus positive report and doctors prescription in Indore.

    The demand for the two injections has shot up following a spurt in coronavirus cases, an official said.

    Meanwhile, a record number of 788 patients tested positive for the virus in Indore district on Monday, taking the tally to 73,224.

    COVID-19 cases in Madhya Pradesh rose “abnormally” after March 14, a senior state health department official said on Monday, adding the positivity rate jumped from 1.1 per cent in the January end to 10.4 per cent in the last seven days.

    He said the cases grew “drastically” compared to the “first peak” seen in September last year.

    “The case positivity rate which was just 1.1 per cent (per 100 tests) during January-end climbed to 10.4 per cent in the last seven days. The number of cases grew abnormally high after March 14. The cases rose by around 15 per cent compared to February,” said Mohammed Suleman, Additional Chief Secretary, Health, Madhya Pradesh.

    He said Madhya Pradesh had recorded the highest number of 2,607 cases in a day on September 19, 2020, which was thought to be the highest peak.

    “However, we are reporting more than 3,300 cases now (in a day),” Suleman said.

    According to the WHO,the positivity rate should ideally remain below five per cent, he added.

    Madhya Pradesh now has 3.4 per cent of the total active cases in India, Suleman said.

    Madhya Pradesh on Sunday recorded 3,178 new cases, taking its tally to 3,06,851, as per the state health department.