Indigenous Manufacturing of Medical Devices and Toys

Feb 09: The value of imports and exports of Medical Devices is given below:


To encourage domestic manufacturing of high-end medical devices to reduce import dependence and to boost domestic manufacturing, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has taken several measures which are as under:

  1. Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of Medical Devices (PLI MD) with a total financial outlay of Rs. 3,420 crore and tenure from FY 2020-21 to FY 2027-28. The financial incentive is given to selected companies at the rate of 5% on incremental sales of medical devices manufactured in India and covered under the four target segments of the scheme, for five (5) years. The four target segments are – (I) Radiotherapy, (II) Imaging Devices, (III) Anaesthesia, Cardio-respiratory & Critical Care, and (IV) Implants. 26 participants have been approved under the scheme, of which 11 are MSMEs.
  1. Production Linked Incentive (PLI) scheme for Pharmaceuticals, with a financial outlay of Rs. 15,000 crores and the tenure from FY 2020-21 to FY 2028-29, provides for financial incentives to 55 selected applicants, which includes five selected applicants of In-Vitro Diagnostics (IVD) devices, of which four are MSMEs. The incentive period under the scheme is six years.
  1. The scheme Promotion of Medical Devices Parks, with a total financial outlay of Rs. 400 crore and a tenure from FY 2020-21 to FY 2024-25, provides for the maximum financial assistance of Rs. 100 crore each to 4 selected States/Union Territories for the creation of Common Infrastructure Facilities in the upcoming Medical Devices Parks. Under the scheme, final approval for financial assistance of Rs. 100 crore each, has been given to the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.
  1. The scheme Assistance to Medical Device Clusters for Common Facilities (AMD-CF) intends to provide financial incentives to Medical device clusters to develop common infrastructure facilities like Medical device testing labs, E-waste treatment facilities, and logistic centres. The scheme will provide financial assistance to National or State level Government or Private institutions interested in establishing or strengthening testing facilities for medical devices. The application window for applicants has been opened in January 2024. MSMEs are eligible for availing of the incentive under the scheme.

Further, the Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry is providing all-round support for creating a conducive manufacturing ecosystem for the Toys industry. Some of the measures include promoting Made in India toys; designing toys based on Indian values, culture, and history; using toys as a learning resource; organizing hackathons and grand challenges for toy designing and manufacturing; monitoring the quality of toys; restricting imports of sub-standard and unsafe toys and promoting indigenous toy clusters. As a result of the various measures taken by the Government, the manufacturing ecosystem Indian Toy industry has witnessed remarkable growth, leading to a substantial decrease of 52% in the overall import of toys from USD 332.55 million in FY 2014-15 to USD 158.66 million in FY 2022-23 and increase of 239% in the exports of toys from USD 96.17 million in FY 2014-15 to USD 325.72 million in FY 2022-23. Steps taken by the Government to further enhance exports of Made in India toys are:

  1. Directorate General of Foreign Trade (DGFT) vide Notification dated 02.12.2019 mandated sample testing of each consignment and no permission for sale unless the quality testing is successful. In case of failure, the consignment is either sent back or destroyed at the cost of the importer.
  1. Basic Custom Duty (BCD) on Toys-HS Code-9503 has been increased from 20% to 60% in February 2020, and subsequently increased to 70% in March 2023.
  1. The Government issued a Toys (Quality Control) Order, 2020 on 25.02.2020 through which toys have been brought under compulsory Bureau of Indian Standards (BIS) certification with effect from 01.01.2021. This QCO applies to both domestic manufacturers as well as foreign manufacturers who intend to export their toys to India.
  1. QCO on Toys was amended on 11.12.2020 to exempt goods and articles manufactured and sold by artisans registered with the Development Commissioner, Ministry of Textiles and also by registered proprietors and authorized users of a product registered as Geographical Indication by the Office of Controller General of Patents, Designs and Trademarks (CGPDTM), Govt. of India (GoI).
  1. BIS made special provisions on 17.12.2020 to grant licenses to micro-scale units manufacturing toys without testing facilities for one year and not to insist on establishing an in-house facility. Subsequently, on industry representation, the relaxation has been extended up to 3 years.
  1. BIS has granted 1454 licenses to domestic manufacturers and 36 licenses to foreign manufacturers for the safety of toys as per IS 9873/IS 15644 as of January 2024.
  1. Under the recent Free Trade Agreements (FTA) including India-UAE Comprehensive Partnership Agreement (CEPA) and India-Australia Economic Cooperation and Trade Agreement Trade (ECTA), the partner countries are providing zero duty market access for exports of Indian toys.

Further to support the MSME sector, the Ministry of MSME is implementing various schemes for providing credit support for new enterprises creation, technology upgradation, skill development and infrastructure development throughout the country including Gujarat.  Under the Scheme of Fund for Regeneration of Traditional Industries (SFURTI), 19 toy clusters have been approved benefitting 10969 artisans, which are as under:

S. No.StateNumber of ClustersTotal Number of Artisans
1Tamil Nadu1460
2Andhra Pradesh1231
4Madhya Pradesh96,218
7Uttar Pradesh21,002
Grand Total1910969

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