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Vidhi Centre for Legal Policy

 



D1 - The purpose of this survey is to take a step towards promoting ease of doing business for tech startups in India. The questions and the responses will be used to guide our research towards understanding the on-ground challenges faced by tech startups in India today and suggest recommendations in the legal and regulatory landscape. All responses will be strictly confidential and used only as data points in our research. Please note that any output based on this survey is for academic research purposes.

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Demographic Questions:
Enter
Organization/Firm Name:
Place of incorporation:
Location of main office:
Name of Respondent:
Email ID :
Phone Number:
What is your primary role in the startup ecosystem?
Other 1
What sector does your tech startup operate in?
Other 2
What kind of technology is your startup based on
Is your start-up a woman led start up?


Company Law (as per Companies Act, 2013 and Rules)


I - Compliances/Obligations
Tick the three most time-consuming procedures Tick the three compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances that influence your decision when choosing the jurisdiction for incorporation Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Incorporation of the Company
Declare commencement of business by filing INC-20A within 180 days of incorporation
Appoint the statutory auditor by filing ADT-1 within 30 days of incorporation
Hold the first board meeting within 30 days of incorporation
File DIR-3 KYC annually for all directors
Submit annual financial statements and audit reports by filing AOC-4 within 30 days of the AGM
Summarize company activities by filing MGT-7 within 60 days of the AGM
Hold at least four board meetings annually, ensuring a maximum gap of 120 days between meetings
File MGT-14 within 30 days of the AGM for shareholder-approved special resolutions
None of the above


I1 - Did you incur significant costs during the initial registration or incorporation of your company?


Tax Law


II - Are you eligible for exemptions under Section 80IAC of the Income Tax Act, 1961?


IIa - Eligibility Criteria to avail benefits under Section 80IAC of the Income Tax Act
Tick the criteria that was most difficult to comply with.
Incorporation on or after the 1st day of April, 2016 but before the 1st day of April, 2019
Registration as a Private Limited Company or Limited Liability Partnership
Total turnover not exceeding twenty-five crore rupees in any of the previous years
Certificate of eligible business from the Inter-Ministerial Board of Certification
None of the above


IIa1 - Eligibility Criteria to avail benefits under Section 80IAC of the Income Tax Act
If you are ineligible under this provision, tick the specific criteria that disqualified you
Incorporation on or after the 1st day of April, 2016 but before the 1st day of April, 2019
Registration as a Private Limited Company or Limited Liability Partnership
Total turnover not exceeding twenty-five crore rupees in any of the previous years
Certificate of eligible business from the Inter-Ministerial Board of Certification
None of the above


IIB - Tax Exemptions for Startups
Tick the exemptions you have availed Tick the exemptions that were difficult to obtain Tick the exemptions that had a positive impact on your business growth
3-year tax holiday
Deferring the deduction of TDS on ESOP prerequisites for employee
10-year period for carry forward of losses
None of the above


IIc - General Tax Compliances(Compliances/Obligations)
Tick the two most time-consuming compliances Tick the two compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Annual Income Tax Returns
Annual Tax Audit (if applicable)
Quarterly TDS/TCS Filing
Monthly/ Quarterly/ Annual GST Filing (if applicable)
Professional Tax (if applicable)
None of the above


Intellectual Property Rights


IIIA1 - Does your startup own any intellectual property?


IIIA2 - If yes, which IP does it own?


IPR Procedure Questions


IIIB1 - Procedure(Patent)
Tick the three most time-consuming stages Tick the three most cost intensive stages Tick the three stages where you faced the maximum regulatory hurdles Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Indian Patent Search
Patent Drafting
Patent Application Filing
Patent Publication for Public Opposition
Request for Examination filed to the Indian Patent Office
Grant of Patent by the Indian Patent Office
None of the above


IIIB2 - Procedure(Trademark )
Tick the three most time-consuming stages Tick the three most cost intensive stages Tick the three stages where you faced the maximum regulatory hurdles Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Trademark Search
Trademark Application Filing
Trademark Application Allotment by the Registrar Office of Trademarks
Vienna Codification
Trademark Examination by the Trademark Officer
Trademark Journal Publication
Trademark Registration by the Registrar Office of Trademarks
None of the above


IIIB3 - Procedure(Copyright)
Tick the three most time-consuming stages Tick the three most cost intensive stages Tick the three stages where you faced the maximum regulatory hurdles Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator.
Submission of Application to the Copyright Office
Diary Number Issuance by the Copyright Office
Copyright Objection Handling
Objection Resolution by the Copyright Office
Application Scrutiny by the Copyright Office
Obtaining the Copyright Registration Certificate
None of the above


III1 -
Yes No
Have you encountered any challenges in enforcing your intellectual property rights during legal proceedings against larger companies?
Does the difficulty or time taken in obtaining various intellectual property rights hamper your business’ innovation?


Data Protection


IVA - Information Technology Act, 2000 Compliances
Tick the three most time-consuming compliances Tick the three most cost-intensive compliances in terms of resources expended Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Implementing security practices to protect sensitive data; liable for damages if not followed, as per the IT Act, 2000
Obtaining consent for disclosing personal information as per the IT Act, 2000
Publish and maintain a compliant privacy policy, as per the IT Rules, 2011
Obtain written consent for sensitive data collection, and inform users about the purpose and retention period, as per the IT Rules, 2011
Not retaining sensitive data longer than necessary, as per the IT Rules, 2011
Obtain user consent before sharing sensitive data with third parties, as per the IT Rules, 2011
Implement and audit a security system at least annually or after significant upgrades, as per the IT Rules, 2011
None of the above


IVB - Potential Exemptions under the The Digital Personal Data Protection Act, 2023


Currently S.17(3) of The Digital Personal Data Protection Act, 2023 states that the Central Government may notify a class of Data Fiduciaries, including startups which may be exempted from certain provisions of the Act. Please answer the following questions, with reference to the potential exemptions that may be offered to startups:
Tick the exemptions that would be beneficial for start-ups
From consent and notice requirement for every request made to a Data Principal
From ensuring completeness, accuracy and consistency of personal data processed for certain purposes
From erasure of personal data upon the Data Principal withdrawing consent or as soon as it reasonable to assume that the specified purpose is no longer being served, unless retention is necessary for compliance with any law.
From being notified as a Significant Data Fiduciary and the consequent conditions to be complied thereunder
From disclosing shared personal data when the Data Fiduciary shares it with an authorized entity for preventing or detecting offences, investigating cyber incidents, or prosecuting offences
None of the above


IV1 - Select your answer
Select
What should be the minimum time period for these exemptions to allow you to procure technology and personnel to ensure compliance?
Is the requirement to notify the Data Protection Board and affected individuals in respect of data breaches practical to implement?
Are periodic data audits (if your startup is qualified as a significant data fiduciary) feasible within your organization?
Will you need to allocate additional resources for compliance with the act?


Environmental Law


VA1 - General Questions
Yes No
Do you access (/have you accessed) the option of self-certifying with certain environment laws for the first 3-5 years, as allowed for start-ups?
Do you think the period for self-certification should be expanded?


VB - Compliance Questions (Compliances/Obligations)
Tick three time-consuming compliances Tick the three compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Mandatory Energy Audits as per the Energy Conservation (Amendment) Act, 2022 [ECA, 2022]
Reporting on Energy Consumption and Savings as per the ECA, 2022
Submission of EPR Action Plans as per the Plastic Waste Management Rules, 2016 [PWMR, 2016] and Extended Producers Responsibility (Chapter IV)
Filing Annual Reports on plastic waste management, details of recycled and processed plastics as per the PWMR, 2016
Submission of annual returns on e-waste management and collection as per the E-Waste (Management) Rules, 2016 [EWMR, 2016] and Extended Producers Responsibility (Chapter IV)
Submission of Environment Impact Assessment (EIA) Reports as per the Environment (Protection) Act, 1986 [EPA, 1986]
General compliance with Environment Standards, as per the EPA, 1986
Filing Public Environment Statements to the SBCB, as per the EPA, 1986
None of the above


Funding


VI1 - General Questions
Select
Which stage of funding is your startup in currently?
Do you think the funding environment in India is favourable for tech startups?
Which funding round posed the greatest challenge in securing investment?
Have you received any foreign funding or investment?


VI5 - If yes, which of the following regulatory compliances have you found challenging to adhere to, if any?


VIB - Funding Procedure Questions
Yes No
Does the unclear legal status of equity crowdfunding create obstacles for your fundraising efforts?
Would providing startups with an exemption to conduct equity crowdfunding help address capital shortages?
Does the limitation of offering private placement to a maximum of 200 individuals per financial year create funding difficulties for your startup?
Do you find the ambiguity surrounding the term "beneficial owner" in Press Note 3 of 2020 to be a challenge when seeking foreign funding?
Have you experienced the pre-approval process for FDI from” beneficial owners” from bordering countries as time-consuming?


Insolvency and Winding Up


VIIA - Has a startup you are working with/have worked with been involved in insolvency proceedings?


VIIB - Insolvency Procedure Questions (Procedure)
Tick the three most time-consuming stages Tick the three most cost intensive stages Tick the three most challenging stages in terms of technical complexity/ resource requirements/ regulatory hurdles Tick the stages which according to you require an amendment in the law or need to be reviewed by the regulator
Application to the NCLT
Appointment of Interim Insolvency Resolution Professional [IRP]
Moratorium
Verification and analysis of claims by the Interim IRP
Appointment of the Resolution Professional by the Committee of Creditors [CoC]
Resolution Plan Approval by the CoC
Liquidation
None of the above


Labour Law


VIII1 - There are some special compliance provisions for startups already in place in India, designed to reduce regulatory burdens.
Under the Labour Laws (Exemption from Furnishing Returns and Maintaining Registers by Certain Establishments) Act, 1988, specific exemptions are provided to simplify compliance for smaller establishments. This Act categorizes establishments into two groups: small establishments, employing 10 to 19 employees in the preceding 12 months, and very small establishments, employing up to 9 employees in the same period, which are allowed to file simplified forms in lieu of returns and registers under certain Acts.

Under the self-certification framework for labour laws, startups are provided with an option to simplify compliance by self-certifying through the Shram Suvidha Portal and are exempt from routine inspections for up to five years unless credible complaints are received.

Enter
Have you accessed the option of self-certifying with labour laws for the first 3-5 years, as allowed for start-ups?
Have you used the Shram Suvidha Portal, developed to allow for a single window access for registration/ licensing related services of employers?
Does your start-up fall under the category of establishments who are able to file simplified returns and registers under the Labour Laws (Exemption from Furnishing Returns and Maintaining Registers by Certain Establishments) Act, 1988?
What is the percentage of women employees in your start-up?


VIIIB - Compliance Questions (Compliances/Obligations)
Tick the five most time-consuming compliances Tick the five compliances with the highest cost for approval or registration Tick the five compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick compliances you avoid by actively limiting your team size under certain thresholds, if applicable Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Filing annual return, as per Payment of Wages Act, 1936 [PWA, 1936]
Maintaining registers of wages, fines, deductions for damages and advances, as per PWA, 1936
Allotment of PF Code
Maintaining registers under the PF Scheme and enrolment of employees
Contribution [10% of basic wages] to an employee’s PF
Filing returns with respect to International Workers if any employed
Registration (within 15 days of the Employees State Insurance Act, 1948 [ESI Act, 1948] becoming applicable)
Filing half-yearly and annual returns, as per ESI Act, 1948
Maintaining a register of employees, as per ESI Act, 1948
Filing monthly declarations, as per ESI Act, 1948
Contribution [3.25% of the wages] as per ESI Act, 1948
Obtain mandatory insurance for gratuity obligation or obtain approval for a gratuity fund from governmental authority, as per the Payment of Gratuity Act 1972 [PGA, 1972]
Pay gratuity at the rate of 15 days' last drawn wages as per the PGA, 1972
Maintaining register of workers and remuneration, as per the Equal Remuneration Act 1976
Constitution of Internal Complaints Committee [ICC], as per the POSH Act 2013
ICC to file annual returns, as per the POSH Act 2013
Maintaining registers in prescribed format, as per the Payment of Bonus Act, 1975 [PBA, 1975]
Filing annual return, as per the PBA, 1975
A minimum bonus of 8.33% to employees earning less than Rs. 21,000, as per the PBA, 1975
Maintaining muster rolls of benefits provided, as per the Rights of Persons with Disabilities Act, 2016 [RPWD Act, 2016]
Maintaining records of employees with disabilities, as per RPWD Act, 2016
Norms of accessibility as per the RPWD Act, 2016
Maintaining register of maternity benefits
Providing creche facilities if more than 50 persons are employed
None of the above


DPIIT/Startup India


IX0 - Have you availed any benefits under the DPIIT StartUp India Scheme?


IX - DPIIT/Startup India(Benefit)
Tick all benefits that you have availed Tick the three benefits that were most challenging to avail Tick three benefits that according to you led to ease of doing business Tick the benefits which require regulatory review
Tax exemptions provided for eligible startups under Section 80-IAC of the Income Tax Act
Self-Certification for Environmental and Labour Laws
Fast-tracking of Startup Patent Applications
Assistance in filing of IP applications
Government to bear facilitation cost for IPR registration
Rebate on filing of application for IPR registration
Opportunity to list product on Government e-Marketplace
Exemption from Prior Experience/Turnover for public procurement
Earnest Money Deposit Exemption for Public Procurement
Access to funding schemes for eligible startups
None of the above


IX1 - Has your startup benefited from government policies like the Startup India scheme and DPIIT recognition?


IX2 - If you are a women-led business, have you faced any specific challenges in business operations?


IX3 - .
Yes No
Have you taken steps towards to make the services provided by your startup more accessible to women?
Do you take any steps to incorporate financial inclusion in your app or service?
Do you ensure your app or service is accessible to people with disabilities?
Is your app or service available in different languages?
Do you incorporate sustainable practices in your business operations?


IX4 - Do you take any steps to incorporate financial inclusion in your app or service?


IX5 - Do you ensure your app or service is accessible to people with disabilities?


IX6 - Is your app or service available in different languages?


IX7 - Do you incorporate sustainable practices in your business operations?


X1 - Which sector does your startup primarily operate in?


XA - Clean-Tech(Compliances/Obligations)
Tick the three most time-consuming compliances Tick the three compliances with the highest cost for obtaining the final approval Tick the three compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Prior Consent from SPCB for Industrial Plants, as per the Air Act, 1981
Regular submission of air quality monitoring data, as per the the Air Act, 1981
Compliance reports to be submitted to SPCBs, as per the the Air Act, 1981
Effluent Discharge Application to SPCB as per the Water Act, 1974
Regular submission of water quality monitoring data, as per the Water Act, 1974
Compliance reports to be submitted to SPCBs, as per the Water Act, 1974
Hazardous Waste Handling Authorization by SPCB, as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 [HOWM Rules, 2016]
Record Maintenance for Waste Handling, as per the HOWM Rules, 2016
Import/Export Hazardous Waste Registration, as per the HOWM Rules, 2016
Importer Annual Return Filing with the SPCB, as per the HOWM Rules, 2016
Export Records Maintenance, as per the HOWM Rules, 2016
Annual Returns for Waste Handlers to SBCB, as per the HOWM Rules, 2016
CPCB Portal Registration, as per the HOWM Rules, 2016
Recycler Record Maintenance, as per the HOWM Rules, 2016
Recycler Returns Filing, as per the HOWM Rules, 2016
Store e-waste for up to 180 days and maintain related records, as per the HOWM Rules, 2016
Solar PV Manufacturer Registration on the CPCB Portal as per the HOWM Rules, 2016
File annual returns on the CPCB portal for solar PV manufacturers, as per the HOWM Rules, 2016
Submit self-declarations on reducing hazardous substances in products, as per the HOWM Rules, 2016
Submission of annual returns on e-waste management, as per the HOWM Rules, 2016
Apply for SPCB registration or renewal for relevant facilities, as per the Plastic Waste Management Rules, 2016 [PWMR Rules, 2016]
Annual report on plastic waste management, as per the PWMR Rules, 2016
Submission of extended producer responsibility action plans, as per the PWMR Rules, 2016
None of the above


XB - Agri-Tech(Compliances/Obligations)
Tick the three most time-consuming compliances Tick the three compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Self-certification on the Geospatial Portal for entities engaged in map-related activities
Registration with APEDA for exporters of scheduled products, as per the Agriculture and Processed Food Products Export Development Authority Act, 1985 [APEDA Act, 1985]
Submission of monthly returns for APEDA-registered exporters, as per the APEDA Act, 1985
Seed certification for entities dealing with seeds, as per the Seeds Act, 1966
Seed stock record maintenance for producers, storage facilities, or distributors, as per the Seeds Act, 1966
Insecticide registration for manufacturers or importers, as per the Insecticides Act, 1968
Insecticide licensing for manufacturers, distributors, or retailers, as per the Insecticides Act, 1968
E-NAM portal registration for entities involved in trading agricultural produce
None of the above


XB1 - Tick the license or approval, for which you entailed a significant cost, which was more than expected:


Fin-Tech


XC1 - What are your primary fintech service/s?


XC2A - Compliances/ Obligations(Payments System)
Tick the most time consuming compliance Tick the compliance with the highest cost for obtaining the final approval Tick the compliance for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Payment system authorization for entities operating a payment system, as per The Payment and Settlement Systems Act, 2007 [PSS Act, 2007]
Prior approval for changes in payment system structure or operations, as per the PSS Act, 2007
Data localization compliance for payment systems, as per the PSS Act, 2007
None of the above


XC2B - Compliances/ Obligations(Payment Aggregator / Cross Border Payment Aggregator)
Tick the three most time-consuming compliances. Tick the three compliances with the highest cost for obtaining the final approval Tick three compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Authorization as a Payment Aggregator, as per RBI Guidelines
Meeting minimum net worth requirements for Payment Aggregators, as per RBI Guidelines
Ensuring merchant compliance with data security standards, as per RBI Guidelines
Maintaining and monitoring escrow accounts with scheduled commercial banks, as per RBI Guidelines
Filing an annual System Audit Report, as per RBI Guidelines
Approval from DPSS, RBI, and Central Office for cross-border payment aggregator operations, as per RBI Guidelines
None of the above


XC2C - Compliances/ Obligations(Account Aggregator)
Tick the three most time-consuming compliances Tick the three compliances with the highest cost for obtaining the final approval Tick three compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
NBFC-AA registration for account aggregators, as per RBI requirements
Meeting net-owned fund requirements for NBFC-AA, as per RBI guidelines
Ensuring data sharing is based on valid customer consent and providing consent revocation functionality, as per RBI guidelines
Conducting an Information System Audit every two years, as per RBI guidelines
Self-assessment of outsourcing arrangements to comply with RBI directions
None of the above


XC2D - Compliances/ Obligations(Prepaid Payment Instruments)
Tick the most time consuming compliance Tick the compliance with the highest cost for obtaining the final approval Tick the compliance for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Authorization for issuing PPIs,, as per RBI Master Directions
Meeting minimum net worth requirements for PPI issuers, as per RBI Master Directions
Submitting a System Audit Report within six months of receiving in-principle PPI approval, as per RBI Master Directions
Maintaining transaction logs for at least 10 years for PPI transactions, as per RBI Master Directions
None of the above


XC2E - Compliances/ Obligations(Digital Lending Platforms)
Tick the most time consuming compliance Tick the compliance with the highest cost for obtaining the final approval Tick the compliance for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Providing Key Fact Statements to borrowers, as per RBI Guidelines
Compliance with data localization requirements for digital lending platforms, as per RBI Guidelines
None of the above


XC2F - Compliances/ Obligations(Peer-to-Peer Lending Platforms)
Tick the most time consuming compliance Tick the compliance with the highest cost for obtaining the final approval Tick the compliance for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Certificate of Registration for NBFC-P2P operations, as per RBI Master Directions
Capping loan maturity at 36 months for P2P lending, as per RBI Master Directions
Updating borrower credit information fortnightly with Credit Information Companies, as per RBI Master Directions
None of the above


XC2G - Compliances/ Obligations(Investment Advisor)
Tick the most time consuming compliance Tick the compliance with the highest cost for obtaining the final approval Tick the compliance for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Registration as an investment advisor, as per SEBI Regulations
Adhering to capped fee limits for investment advisors, as per SEBI Regulations
Maintaining records of client interactions and advice, as per SEBI Regulations
None of the above


XC2H - Compliances/ Obligations(Insurance Broker)
Tick the most time consuming compliance Tick the compliance with the highest cost for obtaining the final approval Tick the compliance for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Certificate of Registration for insurance brokers, as per IRDAI Regulations
Meeting minimum net worth requirements for insurance brokers, as per IRDAI Regulations
Securing professional indemnity insurance within the first year of registration, as per IRDAI Regulations
Maintaining records of risk management services provided to clients, as per IRDAI Regulations
None of the above


XC2I - Compliances/ Obligations(Insurance Aggregator)
Tick the most time consuming compliance Tick the compliance with the highest cost for obtaining the final approval Tick the compliance for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Certificate of Registration for insurance web aggregators, as per IRDAI Regulations.
Meeting initial paid-up capital requirements for insurance brokers, as per IRDAI Regulations
Adhering to regulated fee structures for insurance brokers, as per IRDAI Regulations
Renewing the Certificate of Registration for insurance brokers, as per IRDAI Regulations.
None of the above


Cryptocurrency


Q34 - Have you faced any challenges with compliance due to unclear regulatory guidelines in the cryptocurrency space?


XD - Health-Tech(Compliances Obligations)
Tick the three most time-consuming compliances Tick the three compliances with the highest cost for paper-work such as preparation of application, record keeping etc. Tick the compliances that led to high penalty, late fees, or legal action that had a significant financial impact Tick the compliances which according to you require an amendment in the law or need to be reviewed by the regulator
Registration as a clinical establishment, as per the Clinical Establishments (Registration and Regulation) Act, 2010
Obtaining a license for the sale of drugs, as per the Drugs and Cosmetics Act, 1940. [DCA, 1940]
Maintaining records and registers related to drug sale and distribution, as per the DCA, 1940
License approval for medical devices, as per the Medical Devices Rules, 2017
Implementing telemedicine standards, including informed consent, as per the Telemedicine Practice Guidelines, 2020 [TPG, 2020]
Limitation on prescribing certain categories of drugs, as per the TPG, 2020
None of the above


XD1 - Tick the license or approval, for which you entailed a significant cost, which was more than expected:


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