How to get pollution board certificate for medical devices & surgical products manufacturing

Introduction 

The surgical and medical products manufacturing sectors have experienced significant growth in the last decade. There exists a large gap in the present demand and supply of medical devices in India thereby providing a significant opportunity for their manufacturing in India.

Advantages of starting medical instrument manufacturing business in India

Demand of medical and surgical projects has benefitted government projects which will reach its money value by US$ 50 billion by 2025. Government has also established many schemes which will also increase its demand i.e. Production Linked Incentives (PLI) Scheme for Medical Devices 2020 and establishing medical parks

1.  Surging Demand

Increasing number of medical facilities will hike the demand for medical devices in the market. Multiple government initiatives such as ‘Production Linked Incentives (PLI) Scheme for Medical Devices 2020’ and establishing medical parks will augment demand. This sector in India is projected to reach US$ 50 billion by 2025.

2.  Export Opportunities

The Indian medical device is driven by 75-80% imports from countries like the US, China, and Germany. Also, India and Russia have set the bilateral trade target at US$ 30 billion by 2025. Trade is expected to increase by an additional US$ 5 billion per annum, with opportunities in pharmaceuticals & medical devices, minerals, steel, and chemicals.

3.  Government Policy Support

In October 2021, the government announced plan to draft a new drugs, cosmetics, and medical devices bill for increasing the acceptability of Indian medical devices in the global market.In November 2021, Indian Council of Medical Research (ICMR) collaborated with Indian Institutes of Technology (IITs) to set up ‘ICMR at IITs’ by establishing Centers of Excellence (CoE) for Make-in-India product development and commercialization in the medical devices and diagnostics space.

4.  Growing Investments

This sector has attracted significant investments over the years. In FY20, foreign investments increased 98% to Rs. 2,196 crore (US$ 301.01 million) as against Rs. 1,108 crore (US$ 151.87 million) in FY19. FDI inflow in this sector stood at US$ 2.23 billion between April 2000 and June 2021.

The important registrations and certificates required to set up the factory for surgical and medical products

1.  Determining the status of legal entity
A business owner must first establish a business entity as per his resources, goals, and requirements which can be any of the following:
A sole proprietorship firm means if a single individual is the business owner but generally un recommended for a set up a surgical and medical products manufacturing unit. 
A Private/Public Limited Company would be an ideal business structure for this kind of business activity as it allows the expertise and experience of other individuals to add up the overall expertise required for surgical and medical products manufacturing unit.

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2.  Pollution Control Board Certifications for Surgical and Medical Products Manufacturing Unit Business 

• The surgical and medical products manufacturing business generate both air and water pollutants thereby contaminating the environment when toxic and heavy materials are not rightly processed and disposed of. When such waste is released into the oceans or landfills, hazardous materials intoxicate the environment causing harm to wildlife and humans. In addition to that our waste management infrastructure gets disturbed when materials eligible for recycling go in the garbage bin instead of being reused or repurposed. 
• Industrial emissions contain various toxic gases and when such industrial emissions are released into the environment the air becomes toxic which causes the death of forests, acid rain, photochemical smog which directly affects human health especially the lungs of a human body. Such toxic air can kill humans and other creatures.

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Consent to Establish (CTE)

• The Central Pollution Control Board (CPCB) was set up as a Statutory Organization in September 1974 as per Water (Prevention and Control of Pollution) Act, 1974 and later, for the powers and functions under the Air (Prevention and Control of Pollution) Act, 1981. In the ensuing decades, the Central Pollution Control Board (CPCB) has slowly been passing the functions and responsibilities under the Water Act and Air Act to the State Pollution Control Boards in States and Pollution Control Committees in Union Territories. These State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs) in Union Territories are responsible to monitor, control and reduce the level of Air and Water Pollution in their respective jurisdictions. 
• The business owner is required to apply to the State Pollution Control Board to get the Consent to Establish (CTE) Certificate. After the CTE Certificate is secured, the building, machinery etc could be set up and installed. After this, the applicant is again required to apply online to State Pollution Control Board for the Consent to Operate (CTO). Once the CTO certificate is issued, the business is formally allowed to commence its operations. Also, as the process of surgical and medical products manufacturing is, one of the 17 highly polluting business activities, the business entity is also required to apply online for Hazardous Waste Management Authorization from State Pollution Control Board. This authorization certificate guarantees that the hazardous waste being generated in the surgical and medical products manufacturing is suitably being disposed by an authorized hazardous waste handling facility. 

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The procedure of determination of the category of subject matters of the businesses – 

The determination process is typically based on scores. For measuring air pollution marks will be obtained by recognizing various air pollutants and scoring accordingly out of total marks of 40 and for water pollution such scoring will be similarly out of total marks of 40 and the remaining 20 marks out of 100 is allotted for measuring hazardous waste. If this score of a business activity is higher than 60 then it is called as red category of business activity and so on.

How to apply for Pollution Control Certificate

The simple steps can be followed to understand the procedure of applying for a Pollution Control Certificate:

• The initial application is available on the online portal of any Pollution Control Board or Pollution Control Committee. 
• The applicant is required to submit the documents and submit Government fees for such applications. The fees for Consent to Establish (CTE) and Consent to Operate (CTO) under Air and Water Act largely depends on certain factors such as the type of business activity, commencement of such business, capital investment of the business and the duration of Consent to Operate (CTO) validity.
• The required documents relating to the details of the industry has to be scanned and uploaded while filling the online application and, in some cases, the physical copy of such application along with those scanned documents and receipt of the fees paid has to be sent by post to the Pollution Board Office or Pollution Committee office. 
• The status of a pending applications for Consent to Establish (CTE) or Consent to Operate (CTO) can be checked on the same online portal of SPCB or PCC. 

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Consent to Operate

The industries categorized under red, orange, and green categories need to apply for consent to establish and consent to operate under the Air and Water Acts. The consent to operate/renewal shall be granted for 5 years for precious metal plating industry as it comes under the orange category. The CTO validity for surgical and medical products manufacturing unit could be for one year per renewal application as this is a red category business activity.

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3.  CPCB Plastic EPR Certificate  

The surgical and medical products manufacturing does use lots of plastics and hence registration is mandatory. Registration for Plastic waste can be through CPCB under the Plastic Waste Management (PWM) Rules 2016 and an online portal has been launched in this regard. Producers, importers & Brand-owners are required to fulfil Extended Producers Responsibility (EPR) for the plastic waste generated due to the products introduced by them in the market.

4.  CDSCO Permission for Medical devices Manufacturing 

The medical devices & surgical products thus manufactured are to be certified by the Central Drug Standards Control Organization (CDSCO). The CDSCO would lab test, if required, the device and verify the claims made by the manufacturer/importer of medical devices & surgical instruments

5.  Trademark Registration

The Trademark certificate can be acquired for which an application has to be made through the online portal of the Trademarks & Patents Office and such trademark must be distinct and innovative. Depending on the distinctiveness, the Registrar might approve and provide the certificate of registration of a trademark. Every 10 years you will have to renew the trademark of your firm.

6.  Factory license 

The Factory License is a certification that a particular factory complies with the Municipal Laws and Labor Laws of a particular Municipal Area or of a Gram Panchayat. For acquiring the factory license, one must apply to the Office of the Directorate of Factories. The Factory License is issued for one year and it generally requires renewal after every 31st March of the Financial Year.