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Legal requirements to manufacture drones (Unmanned Aircrafts) in India

Legal requirements to manufacture drone in India

Manufacturing drones [also referred to as Unmanned Aircraft System (UAS) or Remotely Piloted Aircraft System (RPAS)] in India is regulated by multiple laws including: Aircraft Act, 1934, Indian Wireless Telegraphy Act, 1933, Indian Telegraph Act, 1885 and Sea Customs Act, 1878 (as adopted by the Customs Act, 1962).

In this article, we have described the procedure that has to be followed for lawfully manufacturing drones in India.

Step 1- Obtaining Unique Authorization Number (UAN) for Manufacturer

Persons seeking to manufacture a drone have to first obtain a Unique Authorization Number (UAN) from the DGCA under the Unmanned Aircraft System Rules, 2021 (UAS Rules). It is important to note that only Indian citizens, enterprises (firms, partnerships etc.) and companies may seek authorization to manufacture drones.

Prior to making an application for authorization, the manufacturer has to first obtain security clearance from the Ministry of Civil Aviation (MCA) in consultation with Ministry of Home Affairs (MHA). The security clearance application may be made on the government portal https://e-sahaj.gov.in.

Upon receiving the security clearance, the manufacturer will have to submit an application to the DGCA in Form UA – 1 of UAS Rules along with the specified fee. The fee varies for each category of drone.

After the process of authorization is complete, the DGCA will provide a UAN for an authorized manufacturer. This UAN will be valid for a period of 10 years unless suspended, revoked or cancelled.

Any change thereafter to the credentials relevant to the eligibility criteria for obtaining the UAN has to be informed to the DGCA, and a fresh authorization will be issued thereafter if the eligibility conditions continue to be fulfilled.

Step 2 – Obtaining Equipment Type Approval for wireless system used in the Drone

An Equipment Type Approval (ETA) from the Wireless Planning & Coordination (WPC) Wing has to be obtained for every model and make of drone that is sought to be manufactured in India.

ETA can be obtained by making an application in the specified format to a Regional Licensing Officer (RLO) of the WPC Wing. The RLOs are located in Delhi, Mumbai, Kolkata, Chennai and Guwahati. An application form along with the technical literature, radio frequency reports from accredited labs and the requisite fees have to be submitted while applying for ETA.

An ETA issued for particular make and model of a prototype drone can be used by future users of the same make and model.

Step 3 – Obtaining Unique Prototype Identification Number

Any drone which has not been granted a Certificate Manufacture and Airworthiness (CMA) by DGCA cannot be used for sale and marketing purposes. In order to obtain a CMA, first a prototype of the drone has to be manufactured in India for testing at an approved laboratory.

In order to manufacture a prototype drone in India, the authorized manufacturer has to make an application for obtaining a Unique Prototype Identification Number, which is unique to the particular prototype drone and references the serial number. The application to obtain the Unique Prototype Identification Number has to be made as per Form UA – 2 of UAS Rules along with the specified fee.

The Unique Prototype Identification Number received from DCGA has to be affixed on the Prototype drone in an identifiable and visible manner.

Step 4 – Manufacturing a Prototype UAS

An authorized manufacturer can manufacture a prototype drone after obtaining the Unique Prototype Identification Number. The prototype drone is essential for the receiving the CMA.

Step 5 – Obtaining Certificate of Manufacture and Airworthiness (CMA)

Once the prototype drone has been manufactured in India, the authorized manufacturer is required to prove that the prototype drone is ‘airworthy’ i.e. it is capable of airborne operations as per the requirements stipulated by Indian law. A drone is considered to be airworthy only when it receives a Certificate of Manufacture and Airworthiness (CMA) from DGCA.

An authorized manufacturer can obtain a CMA by making an application under Form UA – 3 of UAS Rules to the DGCA with the specified fee. Please note that unmanned aircraft flight manual and maintenance manual should also be prepared and submitted along with Form UA – 3. On receipt of duly filled application, the DGCA allots an approved laboratory for testing of drones. Upon allotment, the authorized manufacturer has to submit the prototype drone which was manufactured in India along with design documents to the testing laboratory. The testing laboratory will test the prototype drone for its design, build and airworthiness. Once the testing laboratory validates the prototype drone and issues a test report, the DGCA will issue a CMA for specific type and class of a drone after being satisfied with the test report.

A drone can be lawfully manufactured in India after ensuring that the requirements stipulated in the steps mentioned above are complied with.

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Legal requirements to import drones (Unmanned Aircrafts) into India

Drone Flying In India Regulations

The import of drones [also referred to as Unmanned Aircraft System (UAS) or Remotely Piloted Aircraft System (RPAS)] into India is governed by multiple laws, including: Aircraft Act, 1934, Indian Wireless Telegraphy Act, 1933, Indian Telegraph Act, 1885, Sea Customs Act, 1878 (as adopted by the Customs Act, 1962), and the Foreign Trade (Development and Regulation) Act, 1992.

The key permission required to secure an import clearance for a drone is the Certificate of Manufacture and Airworthiness from Director General of Civil Aviation (DGCA). However, there are many steps involved in the process of obtaining the said certificate.

In this article, we have described the procedure that has to be adopted before importing drones into India in a step-by-step manner.

Step 1- Obtaining Unique Authorization Number (UAN) for Importer

Persons seeking to import a drone have to first obtain a unique authorization number from the DGCA under the Unmanned Aircraft System Rules, 2021 (UAS Rules). It is important to note that only Indian citizens, enterprises (firms, partnerships etc.) and companies may seek authorization to import drones.

Prior to making an application for authorization, the importer first has to obtain security clearance from the Ministry of Civil Aviation (MCA) in consultation with Ministry of Home Affairs (MHA). The security clearance application may be made on the government portal https://e-sahaj.gov.in.

Upon receiving the security clearance, the importer will have to submit an application to the DGCA in Form UA – 1 of UAS Rules along with the specified fee. The fee varies for each category of drone.

After the process of authorization is complete, the DGCA will provide a Unique Authorization Number (UAN) for an authorized importer. This UAN will be valid for a period of 10 years unless suspended, revoked or cancelled.

Any change thereafter to the credentials relevant to the eligibility criteria for obtaining the UAN has to be informed to the DGCA, and a fresh authorization will be issued thereafter if the eligibility conditions continue to be fulfilled.

Step 2 – Obtaining Equipment Type Approval for wireless system used in the Drone

An Equipment Type Approval (ETA) from the Wireless Planning & Coordination (WPC) Wing has to be obtained for every model and make of drone that is sought to be imported into India. 

ETA can be obtained by making an application in the specified format to a Regional Licensing Officer (RLO) of the WPC Wing. The RLOs are located in Delhi, Mumbai, Kolkata, Chennai and Guwahati. An application form along with the technical literature, radio frequency reports from accredited labs and the requisite fees have to be submitted while applying for ETA.

An ETA issued for particular make and model of a prototype drone can be used by future users of the same make and model.

Step 3 – Obtaining Unique Prototype Identification Number

Only a drone which has been granted a Certificate Manufacture and Airworthiness (CMA) by DGCA may be imported into India for sale and marketing. In order to obtain a CMA, first a prototype of the drone has to be imported into India for testing at an approved laboratory.

In order to import a prototype drone into India, the authorized importer has to make an application for obtaining a Unique Prototype Identification Number, which is unique to the particular prototype drone and references the serial number. The application to obtain the Unique Prototype Identification Number has to be made as per Form UA – 2 of UAS Rules along with the specified fee.

The Unique Prototype Identification Number received from DCGA has to be affixed on the Prototype drone in an identifiable and visible manner.

Step 4 – Obtaining Import Clearance for Import of Prototype UAS

Once the Unique Prototype Identification Number has been obtained, the next step is to make an application for prototype import clearance from DGCA. For seeking import clearance, an authorized importer has to make an application in Form UA – 6 along with the specified fee to the DGCA. Once the import clearance is received, the authorized importer may import the drone after obtaining import authorization from Director General of Foreign Trade (DGFT).

Step 5 – Obtaining IEC and Restricted Imports Authorization for Prototype UAS from DGFT

As per the Foreign Trade Policy, 2015 – 20 (FTP), notified under the Foreign Trade (Development and Regulation) Act, 1992, every person or entity who wishes to import any article into India for commercial purposes is required to obtain an Import – Export Code (IEC) from DGFT.

Furthermore, as per the FTP, articles whose import is ‘restricted’ under the Export and Import (EXIM) policy of India would also require an import authorization from Directorate General of Foreign Trade (DGFT) prior to import into India. The import of drones is restricted under India’s EXIM Policy (with the exception of nano drones). Therefore, import of a prototype drone will also require prior import authorization from DGFT.

An authorized importer can apply for restricted imports authorization on the government portal: https://www.dgft.gov.in/CP/

Step 6 – Obtaining Certificate of Manufacture and Airworthiness (CMA)

Once the prototype drone has been imported into India, the authorized importer is required to prove that the prototype drone is ‘airworthy’ i.e. it is capable of airborne operations as per the requirements stipulated by Indian law. A drone is considered to be airworthy only when it receives a Certificate of Manufacture and Airworthiness (CMA) from DGCA.

An authorized importer can obtain a CMA by making an application under Form UA – 3 of UAS Rules to the DGCA with the specified fee. Please note that unmanned aircraft flight manual and maintenance manual should also be prepared and submitted along with Form UA – 3. On receipt of duly filled application, the DGCA allots an approved laboratory for testing of drones. Upon allotment, the authorized importer has to submit the prototype drone which was imported into India along with design documents to the testing laboratory. The testing laboratory will test the prototype drone for its design, build and airworthiness. Once the testing laboratory validates the prototype drone and issues a test report, the DGCA will issue a CMA for specific type and class of a drone after being satisfied with the test report.

Step 7 – Obtaining Import Clearance for Compliant UAS

Once DGCA issues a CMA for a specific type and class of the drone, the authorized importer is required to make an application for its import clearance. Unlike import clearance for prototype, an import clearance of a compliant drone (i.e. a drone which has received a CMA) will allow the authorized importer to import drones in large quantity and for the purpose of sale and marketing in India. For obtaining import clearance for compliant drone, an application in Form UA – 7 of UAS Rules has to be made to DGCA with the specified fee.

Components or parts of drones which are intended to be imported also have to be approved by the DGCA in advance. An application in Form UA – 8 has to be made to seek import clearance of parts and components. The necessary documents to be submitted will vary depending on the purpose of import. For manufacturing purposes, the applicant needs to submit the manufacturer authorization and CMA. If the purpose of import is for R&D purposes, the R&D authorization and Unique Prototype Identification Number will have to be submitted. If the components or parts are being imported for maintenance, the owner’s authorization and CMA have to be submitted by the applicant.

Step 8 – Obtaining Restricted Imports Authorization for Complaint UAS from DGFT

Note that the restricted imports authorization obtained from the DGFT for prototype drone will not work for compliant drones. Therefore, a fresh restricted import authorization will have to obtained for compliant drones. Please refer to Step 5 in terms of applying for restricted imports authorization in context of importing Compliant UAS.

Exemption for Nano Drone

As of May 2021, Steps 5 and 8, insofar as they relate to obtaining restricted import authorization from DGFT, are not applicable for nano drones i.e. drones which are up to 250 grams in weight, with maximum speed up to 15 meters/second, having maximum attainable height up to 15 meters and range limited to 100 meters from remote pilot, which do not fly beyond visual line of sight and cannot carry a payload. However, this exemption may be revised or removed by DGFT in near future.

Once the requirements stipulated under Step 1 to Step 8 are in place, a drone may be lawfully imported into India.

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New Compliances for Health Research on Drugs, Medical Devices and Cosmetics in India

Woman sitting in laboratory

From September 16, 2019, all research conducted in India which focuses on human diseases or conditions in the context of a drug, medical device or cosmetics will have to be reviewed and overseen by a non-governmental body known as Ethics Committee.

More specifically, from that date, the Drugs and Cosmetics Act, 1940 (DCA) will begin to apply to “biomedical and health research”, which is defined as “research including studies on basic, applied and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioral); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation”. The New Drugs and Clinical Trials Rules, 2019 (NDCTR), notified under the DCA, will make it mandatory for any person, company or institution involved in biomedical and health research regulated by NDCTR to ensure that a registered Ethics Committee reviews and oversees the conduct of the research.

Background

Prior to notification of NDCTR on March 19, 2019, there was no law as such that regulated biomedical and health research carried out on human participants other than such clinical research which involved a ‘new drug’. The Indian Council of Medical Research, India’s apex medical research and scientific body, had published The National Ethical Guidelines for Biomedical and Health Research on Human Subjects but there was no law that could enforce these guidelines on sponsors, professionals and institutions involved in the research. This lacuna in the law has been addressed by NDCTR.  The provisions in NDCTR that relate to biomedical and health research were to take effect after 180 days from March 19, 2019 (i.e. the date of its notification). This time was sought, perhaps, to put the administrative machinery in place, such as the National Ethics Committee Registry for Biomedical and Health Research.

Who will be impacted

Any legal person, whether an individual or company, undertaking any biomedical or health research regulated by NDCTR for academic or business purposes, will have to approach a registered Ethics Committee for approval of the research proposal.

A laundry list of those who may be impacted the most is described below for convenience –

Pharma Companies – Pharma companies usually undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Pharma companies also undertake non-mandatory post-marketing surveillance of pharmaceutical drugs. To the extent that such research concerns the health of the patient, it would have to be approved and overseen by a registered Ethics Committee.

Medical Device Companies – Like pharma companies, medical device companies undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Medical device companies also commission research to analyse secondary health data in patient registries. Such research would have to be approved and overseen by a registered ethics committee.

Cosmetics Companies – Cosmetics companies commission health-related studies from time to time. For example, cosmetic companies pay market research companies to assess the impact of the product from a psychological perspective (e.g. increase in confidence, reduction in stigma related to pimples or scars etc.). Such studies would henceforth be required to be approved and overseen by a registered Ethics Committee.

Diagnostic Companies – Diagnostic companies, especially those operating in the field of precision diagnostics, commission studies on existence and determination of various biological markers that aid in the diagnosis of diseases and conditions prevalent in the Indian market. Such studies would henceforth be required to be overseen by a registered Ethics Committee.

Technology Companies – Some technology companies, such as IBM, offer products and services that help clinicians in making better decisions with respect to the choice of medicines by analyzing a database of patient records (e.g. IBM Watson). Such technology companies, before deploying their products and services that analyze patient data with reference to pharmaceutical drugs, notified medical devices or cosmetics, would require the approval of a registered Ethics Committee.

Contract Research Organizations – There are numerous contract research organizations that undertake comparative Bio-availability and Bio-equivalence studies in India for pharmaceutical drugs that have been in the market for some time (i.e. drugs other than new drugs). Such comparative studies would henceforth be required to be approved and overseen by a registered Ethics Committee.

Market Research Organizations – Many market research organizations collect health data or undertake health-related primary research (e.g. patient interviews) and secondary research (e.g. prescription analysis) to reach certain conclusions for its clients (e.g. distinctive health-related product claims).  Such marketing research organization would also have to submit their research to a registered Ethics Committee for review and approval.

Who will not be impacted

Companies undertaking health research on traditional medicinal products (Ayurvedic, homoeopathic medicines etc.) – The NDCTR have been framed under powers that the Central Government has with respect to pharmaceutical drugs, notified medical devices and cosmetics. Therefore, logically, it does not apply to all other categories of drugs such as ayurvedic medicines and homoeopathic medicines. Since the obligations with respect to biomedical and health research are provided under the NDCTR, these logically cannot apply such other category of drugs due to the inherent limitations of NDCTR.

Companies undertaking health research on non-notified medical devices – The DCA applies to a very small number of notified medical devices at present. Any bio-medical and health research that concerns non-notified medical devices should not be covered by NDCTR.

Food & Beverage companies – The DCA does not apply to food or beverages. A separate legislation, called Food Safety and Standards Act, 2006 (FSSA), regulates the quality of food and beverages sold in India. There is no requirement to obtain an Ethics Committee permission to undertake biomedical and health research related to food products under FSSA.

Educational institutions – Students, academicians and professionals in numerous educational institutions undertake epidemiological research i.e. biomedical and health research that is related to diseases and conditions in general and not related to any particular medicine, notified medical device or cosmetics. Such research should not fall in the scope of NDCTR.

Challenges

Shortage of registered ethics committees – Almost all major research institutions in India have a registered ethics committee that they have formed themselves. Some research institutions who don’t have a registered ‘institutional’ ethics committee of their own seek services of a registered ‘independent’ ethics committee. These ethics committees are registered to review clinical trials on new drugs and investigational notified medical devices. The challenge, however, is that a separate registration is required for ethics committees which will review biomedical and health research proposals. In fact, the authority which will grant such registration to ethics committees was designated only a few days ago by the government (i.e. on September 12, 2019). Therefore, at the time of commissioning biomedical and health research, the sponsor of such must carefully evaluate the ‘registered’ status of the ethics committee who has offered its services.

Lack of clarity in definition – The definition of “biomedical and health research” is very broad, so much that it could arguably extend to research on how a medicine “tastes” or a medical device “feels”. Further, the definition by itself does not restrict the application of NDCTR to research that involves medicines, notified medical device and cosmetics only. It is broad enough to cover “basic research” as well, which is not connected any medicine, medical device or cosmetic but instead concerns research on human body and its constituents. Such expansive interpretation of the scope of the definition is not correct, because the parent law to NDCTR, that is the DCA, is applicable only to drugs, notified medical devices and cosmetics. Therefore, rules made under it, cannot go beyond the scope of DCA.  

Conclusion

In light of the application of NDCTR to biomedical and health research, sponsors of any research that concerns human participants and involves a pharmaceutical drug, notified medical device or cosmetic must be careful to not inadvertently violate NDCTR. A good practice would be to refer all such studies for approval of a duly registered Ethics Committee who may, after review of the study design, itself come to a conclusion that it is within the scope of NDCTR or not. Needless to say, all eligible biomedical and health research should under undertaken after review, and under supervision, of a duly registered Ethics Committee only.