Hospitals Deal with Around 1,000 Compliances Every Year

• A small hospital needs to deal with at least 623 unique compliances in a year*
• Labour compliances account for approximately 31% of the compliance obligations.
• Hospitals must secure at least 100 licences, permissions, and approvals under 58 different acts.

*50-bed hospital with facilities like a diagnostic centre, radiology, pathology lab, and pharmacy operating in a single state.

Bangalore, 20th August 2024: TeamLease Regtech has unveiled its latest report titled ‘Simplifying Compliance Management for Hospitals.’ This comprehensive report delves into the intricate regulatory challenges faced by hospitals nationwide. It examines the existing regulatory landscape, highlights the hurdles, and offers actionable recommendations to help alleviate these complexities.

India’s healthcare sector has witnessed remarkable growth in recent years, with public healthcare expenditure increasing to 2.2% of GDP in FY23. The sector, currently valued at US$372 billion, is poised to reach US$638 billion by 2025. The burgeoning medical tourism industry, currently valued at over $7 billion, is expected to double by 2029, attracting approximately 630,000 international patients in 2023 alone. As a major employment generator, the sector currently employs 7.5 million people as of 2024, underscoring its potential and the need for effective compliance management.

For a typical 50-bed hospital with facilities like a diagnostic centre, radiology, pathology lab, and pharmacy operating in a single state, the report identifies 623 unique regulatory compliances. Of these, 421 (67.5%) are mandated at the union level, 192 (31%) at the state level, and 10 (1.5%) at the municipal level. When compliance frequency is considered, the annual obligations for such a hospital can rise to 967. Additionally, the hospital must secure 100 licences, permissions, and approvals under 58 different acts.

Hospitals must comply with various regulatory requirements, including those under the Narcotic Drugs and Psychotropic Substances Act, 1985, and the Maharashtra Narcotic Drugs and Psychotropic Substances Rules, 1985. This involves submitting annual disclosures regarding the purchase and consumption of manufactured drugs to the licensing authority and maintaining detailed records of drug usage and inventory. The Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015, mandate hospitals to keep patient records for five years, document drug compounding, labelling, dispensing, and maintain prescription records. Moreover, hospitals are required to record and report administered drugs and any cases of communicable diseases. The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, requires hospitals to preserve the names of individuals receiving genetic counselling for two years.

The report further reveals that a hospital must obtain 100 licences across Union, State, and Municipal/Local levels. Labour compliances account for approximately 31%, while industry-specific regulations comprise over 27% of the unique obligations. Factoring in the frequency of these compliances, a hospital may face up to 967 regulatory obligations annually. These obligations multiply as the hospital expands its operations or geographic presence. Managing and tracking all these regulatory requirements can be extremely challenging when relying on Excel sheets and ad-hoc processes. The report concludes with recommendations for regulatory reforms to enhance the ease of doing business and provide modern compliance management solutions for healthcare providers.

Download the full report: Simplifying Compliance Management for Hospitals in India