Tag Archives: medical devices

Indian certification of medical devices

The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED the Scheme that had been launched for Certification of Medical Devices in 2016. The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices. The ICMED 13485 PLUS Scheme was launched digitally today . The Chairperson, Quality Council of India graced the occasion along with other dignitaries.

 ICMED 13485 Plus has been designed to integrate the Quality Management System components and product related quality validation processes through witness testing of products with reference to the defined product standards and specifications. This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements. This scheme will be an end to end quality assurance scheme for the medical devices sector in India.

This scheme provides the much-needed institutional mechanism for assuring the product quality and safety. It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification. This will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.

https://pib.gov.in/PressReleasePage.aspx?PRID=1728368

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faster imports of key medical devices

https://pib.gov.in/PressReleasePage.aspx?PRID=1715152

Considering the present pandemic situation of COVID-19 and for meeting the demand of medical devices, Department of Consumer Affairs, Government of India has permitted the importers of medical devices to import the following categories medical devices for three months from 28.04.2021 onwards, subject to the condition that the importers shall make all declarations required under these rules immediately after import/ custom clearance and before sale by way of stamping or putting sticker or online printing, as the case may be:

(i)         Nebulizers,

(ii)        Oxygen concentrators,

(iii)       Continuous positive airway pressure (CPAP) devices,

(iv)       Bilevel positive airway pressure (BIPAP) devices]

(v)        Oxygen concentrator along with flow meter, regulator, connectors and tubing

(vi)       Vacuum Pressure Swing Absorption (VPSA) and Pressure Swing Absorption (PSA) oxygen plants, Cryogenic Oxygen Air Separation Units (ASUs) producing liquid/ gaseous oxygen

(vii)      Oxygen Cannister

(viii)     Oxygen Filling Systems

(ix)       Oxygen cylinders including cryogenic cylinders

(x)        Oxygen Generators

(xi)       Parts to be used for the manufacture of equipment for production, transportation, distribution or storage of Oxygen

(xii)      Any other device from which Oxygen can be generated

(xiii)     Ventilators (capable of functioning as high-flow devices) with nasal canula; Compressors including all accessories and tubing; humidifiers and Viral filters

(xiv)     High flow nasal canula device with all attachments

(xv)      Helmets for use with non-invasive ventilation

(xvi)     Non-invasive ventilation oronasal masks for ICU ventilators

(xvii)    Non-invasive ventilation nasal masks for ICU ventilators

Department of Consumer Affairs, administers the Legal Metrology Act 2009. The act provides for application of legal requirements to measurements and measuring instruments.  The objective of Legal Metrology is to ensure public guarantee from the point of view of security and accuracy of the weighments and measurements. The Legal Metrology (Packaged Commodities), Rules 2011 are primarily intended to ensure that the consumers are able to make informed choices by being informed of essential declarations on the pre-packed commodities.

The advisory is issued to cater the steep demand for the medical devices mentioned above by enabling the speedy clearance of these goods amid the second wave of Covid in the country. The Government of India has allowed this flexibility for labelling the essential medical devices post custom clearance but before sale for making the expeditious clearance of these life saving devices. The importers, importing the medical devices under this permission shall inform all such imports with quantity imported to the Director (Legal Metrology) and the Controller (Legal Metrology) in the State, where the import is made, immediately after import.

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revised guidelines to promote domestic production of bulk drugs

https://pib.gov.in/PressReleasePage.aspx?PRID=1668347

Union Department of Pharmaceuticals, Ministry of Chemicals and fertilizers has revised the Production Linked Incentive (PLI) Schemes for promoting domestic manufacturing of bulk drugs and medical devices keeping in view the suggestions and comments received from the industry. Accordingly ‘minimum threshold’ investment requirement has been replaced by ‘committed investment’ taking into account availability of technology choices which varies from product to product.

The Department of Pharmaceuticals earlier come out with the following two Production Linked Incentive schemes-

Production Linked Incentive scheme for promotion of domestic manufacturing of critical Key Starting Materials, Drug Intermediates and Active Pharmaceutical Ingredients in India

Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices

Both the schemes were approved by the Cabinet on 20.03.2020 and the detailed guidelines for the implementation of the schemes were issued by the Department on 27.07.2020.

Post issuance of the detailed guidelines, the department received several suggestions and inputs from the pharmaceutical and medical device industry seeking certain amendments in the scheme to enable effective participation of the industry in the two schemes. The suggestions were examined by the respective Technical Committees formed under the schemes. The recommendations of the Technical Committees were placed before the Empowered Committees of the schemes which are chaired by CEO NITI Aayog. After considering the recommendations of the Technical committees, the EC approved the revision of the guidelines for both the schemes. Accordingly, the revised guidelines have been issued today viz 29.10.2020 and are available on the website of the Department of Pharmaceuticals under the tab “schemes”.

The main changes which have been effected in the revised guidelines for Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical Key Starting Materials, Drug Intermediates and Active Pharmaceutical Ingredients in India are as follows:

Replacement of the criteria of ‘minimum threshold’ investment with ‘committed’ investment by the selected applicant. The change has been made to encourage efficient use of productive capital as the amount of investment required to achieve a particular level of production depends upon choice of technology and it also varies from product to product. The provision for verification of the actual investment made by the selected applicant for the purpose of giving incentives under the scheme continues.

Deletion of the provision which restricts the sales of eligible products to domestic sales only, for the purpose of eligibility of receiving incentives, bringing the scheme in line with other PLI schemes and encouraging market diversification.

Change in the minimum annual production capacity for 10 products viz Tetracycline, Neomycin, Para Amino Phenol (PAP), Meropenem, Artesunate, Losartan, Telmisartan, Acyclovir, Ciprofloxacin and Aspirin. Minimum annual production capacity is a part of eligibility criteria under the scheme.

The last date for receiving applications under the scheme is now extended by a week to 30.11.2020 (inclusive)

Similarly, the main changes which have been effected in the revised guidelines for Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices are as follows-

Replacement of the criteria of ‘minimum threshold’ investment with ‘committed’ investment by the selected applicant. The change has been made to encourage efficient use of productive capital as the amount of investment required to achieve a particular level of production depends upon technology used and it also varies from product to product. The provision for verification of the actual investment made by the selected applicant for the purpose of giving incentives under the scheme continues.

Change in the eligibility criteria of minimum sales threshold in line with projected demand, technology trend and market development, for the purpose of availing incentive under the scheme.

The tenure of the scheme has been extended by one year keeping in view the capital expenditure expected to be done by the selected applicants in FY 2021-22. Accordingly, the sales for the purpose of availing incentives will be accounted for 5 years starting from FY 2022-2023 instead of FY 2021-2022.

The last date for receiving applications under the scheme is now extended by a week to 30.11.2020 (inclusive)

The Indian pharmaceutical industry is the third largest globally in terms of volume and contributes significantly to India’s economic growth and export earnings. The Medical Devices industry is identified as a sunrise sector with great potential for diversification and employment generation. The Government of India has launched several initiatives to support the Pharmaceutical and Medical Devices industry to reach their potential in the coming years.

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CSR – covid drugs

MCA has vide its notification dated 24th August, 2020 amended Schedule VII of the Companies Act, 2013 to include the following .

The amendment has been carried out in Rule 2(1)(e) – the rule presently reads as under:

e) “CSR Policy” relates to the activities to be undertaken by the 3[company in areas or subjects] specified in Schedule VII to the Act and the expenditure thereon, excluding activities undertaken in pursuance of normal course of business of a company;

Now vide this amendment, a proviso has been added to this rule, as follows:

“Provided that any company engaged in research and development activity of new vaccine, drugs and medical devices in their normal course of business may undertake research and development activity of new vaccine, drugs and medical devices related to COVID-19 for financial years 2020-21, 2021-22 and 2022-23 subject to the conditions that-
(i) such research and development activities shall be carried out in collaboration with any of the institutes or organisations mentioned in item (ix) of Schedule VII to the Act.
(ii) details of such activity shall be disclosed separately in the Annual Report on CSR included in the Board’s Report”.

So basically companies in pharma business undertaking research and development into covid drugs, trials etc. can take that expenditure as CSR expenditure provided they are collaborating with one of the institutes or organisations mentioned in item (ix) of the said schedule. And details of such activity has to be disclosed separately in the annual report in the item on CSR.

These institutes are : public funded Universities, Indian Institute of Technology (IITs), National Laboratories and Autonomous Bodies (established under the auspices of Indian Council of Agricultural Research (ICAR), Indian Council of Medical Research (ICMR), Council of Scientific and Industrial Research (CSIR), Department of Atomic Energy (DAE), Defence Research and Development Organisation (DRDO), [Department of Biotechnology (DBT)], Department of Science and Technology (DST), Ministry of Electronics and Information Technology).

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