PHARMA LITERATI

Union health ministry has notified that all medical devices will now be regulated under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for effective compliance. The ministry after consultation with Drugs Technical Advisory Board (DTAB) has further notified to amend the Medical Devices Rules, 2017 and has specified that these rules may be called the Medical Devices (Amendment) Rules, 2020 and shall come into force on April 1, 2020. According to a Gazette Notification dated February 11, 2020, after consultation with DTAB, the health ministry hereby specifies that all medical devices intended for use in human beings or animals will be regulated as drugs with effect from the April 1, 2020, which includes all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals...

With the central drug regulator now planning to regulate all medical devices under Drugs and Cosmetics (D&C) Act in a phase wise manner, the Union health ministry is planning to upgrade manpower at Central Drugs Standard Control Organisation (CDSCO) towards effective licensing and enforcement activities to ensure safety, quality and performance of medical devices. Considering that bringing all medical devices into regulatory control will lead to increase in work load considerably, a total of 754 CDSCO regulatory officers and laboratories staff will be inducted into the existing manpower of 119 regulatory and lab staff at CDSCO before implementation of the second phase. As per the road map outlined till 2020, the ministry has set out to upgrade CDSCO manpower by creating additional 1,195 new posts, including 64 experts, and additional 4,300 personnel for new laboratories, mobile drug testing labs, e-governance and training. CDSCO has...

The Union health ministry will soon notify the medical devices like surgical gowns, surgical drapes and incision drapes as 'drugs' under Section 3(b)(iv) of the Drugs & Cosmetics (D&C) Act, 1940. Medical devices are defined as ‘drugs’ under the D&C Act for the purpose of regulating prices and quality control and also for regulating under the Medical Device (MD) Rules 2017. The proposal to add these devices to the notified list was approved by the 82nd Drugs Technical Advisory Board (DTAB) at its meet recently. Once a medical device is notified, manufacturers and importers will have to get the regulatory body’s nod to sell these products in the domestic market.  In this connection, a public notice was uploaded on Central Drugs Standard Control Organisation (CDSCO) website dated 27 November 2018 for stakeholders review/suggestions within 45 days of the issue of the notice. This was followed by DTAB approval in March this year for the regulation of surgical drapes...

The working pharmacists and regulatory officers across the country are planning to bring a proposal before the Drugs Consultative Committee (DCC) of the Union health ministry to make the registered pharmacists the sole authority to keep and sell medicines in the country. Their demand comes in the wake of the ministry's decision to amend D&C Rules to replace 'chemists & druggists' with 'pharmacy' to give retail trade a better professional recognition. They want the government to revoke Schedule K (5) in the D&C Act which mandates doctors to stock and 'supply' medicines to their own patients visiting their clinics or hospitals. The term 'supply' should be removed and the word, 'dispensing' should be inserted in the clause by specifying pharmacist's right to handle medicines even in clinics or hospitals run by medical professionals. In the next DCC meeting, expected to be held in May, the Drugs Controller of Odisha, Ma...

The Central Drugs Standard Control Organisation (CDSCO) has come out with an action plan to regulate all medical devices under Drugs and Cosmetics (D&C) Act in a phase wise manner to ensure safety, quality and performance of medical devices. This will also include diagnostic kits manufactured and imported in the country.  As of today, only 23 categories of medical devices are regulated under the provisions of D&C Act 1940 which cover around 400 medical devices amongst the 5,000 odd unregulated medical devices which pose risk to patient safety.  Many of the medical devices like equipment, analysers, instruments, etc. used in healthcare facilities for diagnosis, treatment and mitigation are currently out of the scope of regulation under D&C Act. The union health ministry had earlier constituted a committee on the issue. After detailed deliberations with different stakeholders, the committee has finally recommended that all medical devices should...

The Drugs Technical Advisory Board (DTAB) of the Union health ministry has constituted a sub-committee to evaluate 324 irrational fixed dose combinations (FDCs) based on Prof C K Kokate Committee final report and has directed the sub-committee to come out with final report in three months time. The matter was deliberated at the 82nd meeting of the DTAB held on April 2, 2019.  The sub-committee has been formed under the chairpersonship of Dr Nilima Kshirsagar, Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), Mumbai to evaluate Kokate Committee report on 324 FDCs considered as irrational.  After examining 418 applications of FDCs, the Kokate Committee found 324 FDCs as irrational, 28 FDCs as rational, 2 FDCs require further generation of data and 4 FDCs require further deliberation after evaluating all the data submitted.  It was also observed that out of the remaining 60 FDCs, 48 FDCs have been prohibited, 11 FDCs have been alread...