Biocon Limited has announced a significant regulatory milestone with its wholly owned subsidiary Biocon Pharma Limited receiving approval from the U.S. Food and Drug Administration (U.S. FDA) for Everolimus Tablets for Oral Suspension. The company notified stock exchanges about this development on January 12, 2026.

FDA Approval Details

The U.S. FDA has approved Biocon Pharma Limited's Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension across three different strengths. The approval encompasses a comprehensive range of dosing options for healthcare providers.

Therapeutic Applications

The approved Everolimus Tablets for Oral Suspension serve specific medical indications related to Tuberous Sclerosis Complex (TSC). The medication addresses two distinct patient populations with different age requirements and treatment purposes.

Primary Indications:

• SEGA Treatment: For adult and pediatric patients aged 1 year and older with Tuberous Sclerosis Complex who have Subependymal Giant Cell Astrocytoma
• Seizure Management: For adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures

Strategic Impact

According to the company's notification to stock exchanges, this FDA approval will further strengthen Biocon's portfolio of vertically integrated drug products. The approval represents an expansion of the company's presence in the U.S. pharmaceutical market through its specialized oncology and rare disease treatment offerings.

The regulatory milestone demonstrates Biocon Pharma Limited's capability to successfully navigate the complex U.S. FDA approval process for specialized therapeutic products. This achievement adds to the company's growing portfolio of approved pharmaceutical products in international markets.

Biocon Executive Chairperson Kiran Mazumdar-Shaw has publicly criticized the Andhra Pradesh government's employment reservation policy, describing it as detrimental to business operations. Her comments address the Andhra Pradesh Employment of Local Candidates in Industries/Factories Act, which mandates 75% job reservation for eligible local candidates in private sector positions.

Policy Details and Implementation

The controversial legislation was enacted in 2019 and has been actively enforced since October 2019, according to a recent RTI reply cited by South First. The Act specifically targets private industries and factories, requiring them to reserve three-quarters of their positions for local workers who meet eligibility criteria.

Mazumdar-Shaw's Position

Responding to social media discussions about the policy, Mazumdar-Shaw expressed strong disagreement with the mandate. "I do not agree with this mandate. I always believe that companies will give preference to locals if they have the required skills," she posted on X. "If not, then such policies are detrimental to businesses."

This stance aligns with her previous comments on similar legislation. The Biocon chief had earlier advocated for exemptions for highly skilled labor when Karnataka's government approved a draft bill mandating 50% reservation for locals in management positions and 70% in non-management categories.

Public Response and Debate

The Executive Chairperson's comments have generated significant discussion on social media platforms. Critics argue that the policy ensures job security for locals without compromising qualification standards. One user questioned why locals should compete with migrants for employment opportunities in their home state, particularly given the incentives provided to companies.

Supporters of regional employment policies contend that reservation systems should exist for both education and employment sectors. They argue that such policies enable cities to develop based on unique local skills and cultural strengths while promoting balanced industrial distribution across regions.

Skills Versus Regional Preferences

The debate highlights fundamental tensions between merit-based hiring and regional employment security. While some social media users support Mazumdar-Shaw's emphasis on skills as the primary hiring criterion, others advocate for mandatory local participation in employment opportunities, especially in regions where companies receive government incentives and support.

The controversy reflects broader policy discussions about balancing business flexibility with local employment generation, particularly in states seeking to attract industrial investment while ensuring benefits reach local populations.