Safety First India Report

Summary

• India could soon strengthen and broaden its regulation of medical devices, potentially recommending safety-engineered devices to help protect healthcare workers from needlestick injuries and infections. This is already reflected in some states where using safety devices is being mandated.
• Right now, Indian healthcare managers are already very aware of the need to prevent needlestick injuries, especially to attract and retain much-needed doctors and nurses given the critical shortage of healthcare professionals.
• Growth is also being driven by factors like protecting healthcare workers in home settings, the trend toward homecare, the need for self-injection of biological therapies, and ensuring the well-being of caregivers in non-medical environments.
• Data showing rapid sales growth of safety-engineered syringes in India (with a CAGR of 19%) provides concrete proof that more healthcare managers are choosing safety devices to protect both staff and home caregivers.

Introduction

It’s been nearly 20 years since needlestick and sharps safety laws were introduced in the USA, and over six years since similar regulations were enacted in the EU. The situation in India, however, is different.

For many years, India’s regulations for medical devices have been under-developed. Until recently, only 22 types of medical devices were notified under the Drugs and Cosmetics Act of 1940, which must be registered with the regulatory body CDCSO. But big changes are coming.

In October 2019, India’s health ministry announced plans to register and regulate all medical devices like drugs, prompted by long-standing safety and quality concerns. The decision came following media investigations into persistent worries¹ about an under-regulated medical device industry that, in some cases, was harming patients.

Earlier in 2019, India’s Drugs Technical Advisory Board suggested that the government should improve its systems for tracking medical devices and reporting safety events. Media coverage² highlighted that the health ministry was concerned that “many medical devices are not yet regulated and are available in the market without any certification or regulatory control, putting patient safety at risk.”

This is a major leap forward for medical device regulation. Although India began registering syringes and infusion sets in 1980, only about two dozen more medical products have since been added to the list of regulated devices. Going forward, however, all devices will be required to register and meet official standards. The Ministry of Health has made it clear³ that “…the Drugs Technical Advisory Board hereby specifies the following devices for use in humans or animals as drugs effective from December 1, 2019… all devices including instruments, apparatus, appliances, implants, materials, or other articles, whether used alone or in combination…” The new regulations will eventually cover all devices, including those for diagnosis, monitoring, treatment, as well as life-support and birth control.

This tightening of India’s regulatory regime indicates a future where safety devices, which greatly reduce needlestick risks, will at least be recommended, if not mandatory. Syringes are actually among the few currently regulated products out of the 22 device types. The current list⁴ includes disposable hypodermic syringes, catheters, and IV cannulae. Category 119 covers syringes with needle-shielding safety features, Category 118 is for Re-use Prevention Syringes (RUP) for therapeutic injections, and Category 115 mentions Auto-Disable (AD) syringes.

These last two categories matter, as they often (but not always) provide safety features that overlap with those specifically designed for safety. Recent media reports⁵ say the Health Ministry is considering a proposal to limit government hospitals to buying only “reuse prevention” (RUP) or “auto-disable” (AD) syringes, as part of efforts to control infections. Some states have already acted ahead of national law; for example, Andhra Pradesh was the first to require Auto-Disable Syringes for all clinical use, declaring itself a “Safety Injection Use State”⁶. The benefits are clear, as one Infection Control Head in Kolkata points out: “Using safety devices can reduce needlestick injuries by eighty percent.⁷”

This paper reviews trends in safety syringe demand in India and the likely factors behind this demand.

Background

– compliance trends
Needlestick injuries put healthcare workers at risk of bloodborne viruses like HIV, hepatitis B, and hepatitis C. While modern treatments can cure hepatitis C, treatment is still expensive and disruptive, and there is no vaccine.

This is a major issue. More research literature in India focuses on needlestick injuries and exposures to bloodborne pathogens among healthcare workers than on other hospital-related conditions. Studies show that 33% to 75% of Indian hospital staff suffer at least one needlestick injury each year⁸.

Indian hospitals and health organizations are increasingly aware of, and concerned about, needlestick injuries and their effects on both staff and reputation. Private hospitals are especially motivated to present a cutting-edge image to attract international medical tourists.

A recent study⁹ also notes, “Healthcare facilities are increasingly seeking accreditation from the National Accreditation Board for Hospitals and Healthcare Providers (NABH) and Joint Commission International (JCI). All these accreditation bodies emphasize implementing needlestick injury (NSI) protocols and occupational safety for healthcare workers, and accredited facilities have clear policies and procedures in place.”

Using safety devices is regularly recommended for reducing needlestick injuries. For example, one article¹⁰ says, “There is significant room for improvement in protecting healthcare workers from NSI, achievable through comprehensive programs addressing institutional behaviors and device factors, considering alternatives to needles whenever possible, and using newer safety-featured devices.” A leading Ahmedabad specialist¹¹ summed it up: “Treatment is a thousand times costlier than prevention.”

In India, keeping healthcare workers safe from needlestick injuries and other risks is crucial for the health system to function. The country faces a severe shortage of nurses, with only 1.7 per 1,000 people versus the WHO’s recommended 2.5, totaling an overall shortfall of 2.5 million nurses¹². There is also a shortage of about 600,000 doctors nationwide¹³.

The economic impact of not addressing needlestick injuries and not using safety devices is well documented, including treatment costs, lost work time, increased absenteeism due to work stress, and more¹⁴. Besides the ethical case—that workers shouldn’t face avoidable risks at work—there’s the practical fact that failing to protect healthcare workers, especially when they are already in short supply, makes these jobs less appealing and harms recruiting efforts. This is especially relevant since India’s Ayushman Bharat initiative is rapidly expanding healthcare and driving demand for professionals¹⁵.

Using safety devices is clearly a priority in the minds of India’s health experts. An NABH assessor in New Delhi¹⁶ was quoted saying, “Blood-filled needle injuries make healthcare workers vulnerable to bloodborne pathogens and life-threatening diseases… The good news is that most infections from needlestick injuries can be prevented… Education and training around NSI prevention and safety-engineered device use can significantly lower infection rates.”

Experiences in Western countries support this view. After the US passed its safety syringe law, needlestick injuries dropped by around 30%¹⁷. The latest independent European survey¹⁸ (by the European Biosafety Network) found about 70% compliance with safety injection devices in EU countries, falling to 60% in homecare settings.

Safety-engineered

devices

– acute care and self-administration both increase demand

The home environment deserves special attention when it comes to safety devices. Aging populations—a global trend—lead to more chronic illnesses¹⁹. Pressure on healthcare systems comes not just from people living longer, but also from rising obesity²⁰, diabetes (India has the highest number of diabetes patients globally²¹), cancer, and heart disease in younger populations. As a result, countries are pushing for more patient self-injection of therapies whenever practical and effective²². As one commentator put it, “The focus is now on providing safe, reliable, and convenient self-administration so patients can manage without extra disruption to daily life and avoid clinic visits for medication²³.”

Most new drugs coming to market are biologics, and the top-selling products are now biologic medications. Although high costs have limited access, the expiration of some biologic patents means biosimilars are becoming available, lowering costs and expanding the market. According to a 2017 Associated Chambers of Commerce of India report, the Indian biosimilars market was $2.2B in 2017 and could hit $40B by 2030²⁴.

Biologic drugs matter because for many diseases—sometimes inherited ones—they offer the best or only effective treatment. Biologics and their biosimilars are usually injected under the skin (due to their size) and must be given regularly for chronic diseases including neurological, cardiac, and autoimmune diseases (like Crohn’s, rheumatoid arthritis, psoriasis, etc.). Self-injection at home is the most cost-effective way to deliver these treatments, and increases demand for devices that make injections easier, promoting better compliance.

As home self-injection goes up, so does the need for safety with sharps outside clinics or hospitals. Until recently, the focus has largely been on compliance for professionals—but that’s changing. Protecting safety in all environments makes it easier to recruit and retain healthcare workers, and safety devices are a cheap, effective way to eliminate unnecessary risks—even for those making home visits. Injuries can also affect waste disposal or other support workers, raising legal liability issues.

Patient needs also play a role. Older patients are often cared for by spouses or family. Protecting caregivers is important—not just from a moral perspective but also to ensure patients’ families stay healthy and stress-free.

Safety device growth

– clear evidence

Is growth in safety device use supported by the facts? The market data says yes.

Before reviewing the numbers, it’s important to mention the need for user convenience with self-administration devices. Older users often have less dexterity, so self-injection devices need to be as simple and easy to operate as possible, with features like passive needle shielding. A patient who is weak needs a device that’s easy to hold, requiring little force. This has helped drive demand for auto-injector devices and prefilled safety syringes that offer user-friendly operation. Devices with automatic needle retraction meet both ease-of-use and safety goals. India’s upcoming regulations are expected to recognize product certifications from US or European agencies—for example, the FDA now requires “human factors” data on ease of use and risk reduction for drug-device submissions.

The data shows safety syringe adoption is climbing quickly in India. A recent report²⁵ says Auto Disable (AD)/safety syringes and needles now have the second-largest market share by revenue. The Indian AD/safety syringes and needles market is expected to grow at a 19% CAGR through 2020 and keep growing strongly. Another source²⁶ notes, “China and India are expected to see a massive growth spurt in the retractable needle industry, with India’s market forecast to double in the near future.”

Conclusion

This paper has highlighted several key factors increasing demand for safety-engineered syringes in India’s healthcare sector: the new drive for stronger medical device regulation, the need to protect workers in hospitals and at home, cost pressures driving patient self-injection and homecare, growing demand for easy-to-use injection devices as populations age, and the rapid expansion of India’s biologic drug market.

Market projections clearly point to fast-growing demand for safety devices. Safety-engineered products are gaining a dominant market position in terms of value. In short, the safety device market in India offers strong and sustainable growth potential in the near future.