Setback: Mylan proposal for Hydroxychloroquine Sulfate Tablet rejected by CDSCO panel

New Delhi: In a major setback to Mylan Laboratories, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has rejected the drug maker's proposal to manufacture and market Hydroxychloroquine Sulfate Tablet 100 mg in India, citing inadequate data.

This came after Mylan Laboratories presented a proposal for the manufacturing and marketing of Hydroxychloroquine Sulfate Tablet 100 mg in India, which included a request for a waiver of the bioequivalence (BE) and clinical trial (CT) studies.

Hydroxychloroquine Sulfate is a synthetic derivative of quinolyl with chemotherapeutic and antibiotic properties. Hydroxychloroquine Sulfate acts against erythrocytic malarial parasites (Plasmodium vivax, ovale, and malariae) by concentrating in food vacuoles. It inhibits plasmodial heme polymerase and acts through other unknown mechanisms.

Hydroxychloroquine also has anti-inflammatory properties and is used in the treatment of rheumatoid arthritis and lupus erythematosus.

Both chloroquine and hydroxychloroquine are being studied as potential treatments for SARS-CoV-2. However, on June 15, 2020, the FDA withdrew the emergency use authorisation for hydroxychloroquine and chloroquine for the treatment of COVID-19.

The committee at its 73rd SEC meeting for Analgesics and Rheumatology, thoroughly examined Mylan Laboratorie's proposal for the manufacturing and marketing of Hydroxychloroquine Sulfate with a request for a waiver of the BE and CT studies.

After detailed deliberation, the committee opined that the data presented by the firm for Hydroxychloroquine Sulfate Tablet 100mg was not adequate.

Accordingly, the committee did not recommend approval of the product.