Aligning India's Smile

Indian Government's Support in Revolutionizing the Clear Aligner Industry

The clear aligner market in India is growing rapidly, fueled by advancements in technology, increasing demand for aesthetic dentistry, and rising disposable incomes. The Indian government is playing a crucial role in this growth by implementing policies, introducing subsidies, and encouraging local manufacturing under its flagship programs. Here's how the Indian government is supporting the clear aligner market and paving the way for its bright future.

Regulatory Framework for Safety and Quality

Central Drugs Standard Control Organization (CDSCO)

The CDSCO is India’s primary regulatory body for medical devices, ensuring the safety and quality of clear aligners:

• Aligners are classified as medical devices, requiring registration and approval for manufacturing and imports.

• Strict quality control measures are in place to ensure compliance with international standards, increasing consumer trust.

Medical Device Rules (2017)

The Medical Device Rules introduced in 2017 streamline the approval process for medical devices, including clear aligners.

• Faster approvals and clear classification systems under this framework encourage manufacturers to bring innovative aligners to market.

Government Initiatives to Boost Local Manufacturing

Make in India Campaign

Under the Make in India initiative, the government promotes the domestic production of medical devices, including clear aligners, by offering:

• Subsidies: Financial incentives for manufacturing units.

• Reduced Import Duties: Lower tariffs on raw materials required for aligner production.

• Tax Holidays: Exemptions for new manufacturing plants for up to five years.

Indian startups like Toothsi, Flash Orthodontics, and Snazzy Aligners are leveraging these benefits to scale their operations and reduce dependency on imports.

Production Linked Incentive (PLI) Scheme

The PLI scheme for medical devices provides financial incentives to companies that manufacture high-value medical devices, including aligners.

• The scheme allocates significant funds to promote domestic innovation and reduce costs for Indian consumers.

• This initiative has attracted global players to set up manufacturing facilities in India.

Expanding Access to Orthodontic Care

Ayushman Bharat Scheme

Under Ayushman Bharat, India’s largest healthcare initiative, dental treatments are being made accessible to underserved regions:

• Aligner treatments are gaining traction as a part of oral care campaigns.

• Public health centers are beginning to include basic orthodontic services, creating awareness about advanced options like clear aligners.

National Oral Health Program (NOHP)

The NOHP, led by the Ministry of Health and Family Welfare, aims to improve oral health awareness across India.

• Campaigns under the program educate the population about the benefits of clear aligners over traditional braces.

• School-based oral health initiatives include clear aligners in their awareness modules for teenagers.

Support for Technological Advancements

Startup India Program

The Startup India initiative supports dental technology startups through funding, mentorship, and tax benefits:

• Many aligner startups in India have received grants to develop innovative solutions.

• Programs like the Biotechnology Ignition Grant (BIG) encourage research in biocompatible materials for aligners.

Digital India Campaign

The government’s push toward digital healthcare is benefiting tele-dentistry platforms:

• Regulations for telemedicine allow orthodontists to prescribe clear aligners remotely.

• Startups are leveraging AI and 3D printing technologies, aligning with Digital India’s focus on healthcare innovation.

Financial Incentives and Insurance Coverage

GST Rate Reduction

The Indian government has reduced GST on medical devices, making clear aligners more affordable for consumers.

Health Insurance Inclusion

While orthodontic treatments were historically excluded from insurance coverage, private insurers are now including clear aligners under advanced dental care plans. The government’s encouragement of health insurance penetration through schemes like Ayushman Bharat indirectly supports this trend.

EMI Options and Tax Deductions

• Dental care financing options such as zero-cost EMIs are being supported by collaborations between banks and aligner providers.

• Tax deductions under Section 80D of the Income Tax Act are also applicable for orthodontic treatments, including aligners, if covered under health insurance.

Public-Private Partnerships for Greater Reach

The Indian government is fostering partnerships with private players to ensure that orthodontic care, including aligners, reaches rural areas:

• Programs like e-Sanjeevani facilitate tele-dentistry consultations, allowing orthodontists to prescribe aligners remotely.

• Collaboration with private dental colleges and hospitals is helping spread awareness about clear aligner treatments in Tier 2 and Tier 3 cities.

Challenges and Opportunities

Challenges

• Cost Barriers: Despite declining prices, aligners remain unaffordable for a significant portion of the population.

• Rural Access: The lack of dental specialists in rural areas limits the adoption of clear aligners.

Opportunities

• Scaling Awareness: Government campaigns like NOHP can further highlight the benefits of aligners.

• Local Innovation: Supporting startups in AI, 3D printing, and tele-dentistry will drive further growth.

The Road Ahead

The Indian government’s proactive approach to supporting the clear aligner market is laying a strong foundation for future growth. With initiatives like Make in India and Ayushman Bharat, combined with technological advancements and regulatory clarity, India is poised to become a global hub for affordable, high-quality clear aligners.

As awareness grows and costs decline, the dream of a perfect smile will become a reality for millions across the nation.