Schedule M of the Drugs and Cosmetics Rules, 1945: Updated

Context: On January 8, 2024, the Union Health Ministry introduced updated regulations in Schedule M of the Drugs and Cosmetics Rules, 1945, aiming to strengthen the oversight of pharmaceutical and biopharmaceutical products.

Good Manufacturing Practices (GMP) for Pharmaceutical Companies:

• GMP functions as a framework ensuring consistent production and control of products in adherence to quality standards. It seeks to mitigate risks in pharmaceutical production that cannot be addressed solely through final product testing.
• The World Health Organization (WHO) provides extensive GMP guidelines, with various countries developing their specific requirements based on WHO GMP.
• Regional bodies such as ASEAN and the EU synchronize their requirements through the Pharmaceutical Inspection Convention.

GMP for Pharmaceutical Companies in India:

• In India, GMP is obligatory, ensuring product quality through control over materials, methods, machines, processes, personnel, and facility/environment.
• Originally incorporated in Schedule M of the Drugs and Cosmetics Rules in 1988, the last amendment occurred in 2005. The recent amendment replaced 'GMP' with 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.'

Revised Schedule M of Drugs: Need and Changes Introduced

• To align with global standards, particularly those of the WHO, and guarantee globally accepted drug quality, the Ministry revised Schedule M. Changes introduced include the incorporation of a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), Qualification and Validation of Equipment, and a Computerized Storage System for all drug products.
• The revised rules underscore manufacturers' responsibility for product quality, compliance with license requirements, and patient safety.

Implementation of Revised Schedule M Rules:

Implementation of the revised rules is based on company turnovers: Small and medium manufacturers (annual turnover less than ₹250 crore) must comply within 12 months, while large manufacturers (annual turnover exceeding ₹250 crore) have a six-month timeframe for implementation.

Significance of Government's Revision of Schedule M:

• This revision is a positive development for the Indian pharmaceutical sector, enhancing and modernizing the quality standards of medicines.
• It reinforces the industry's standing, enhances patient outcomes, and ensures compliance with international quality standards.
• The emphasis on risk management, equipment qualification and validation, and self-inspection significantly contributes to the sector's progress.

Sohrai paintings

Context: On January 8, 2024, a secluded village in Bengal embraced the commencement of the New Year by hosting a workshop dedicated to the ancient indigenous art form known as Sohrai Painting.

About Sohrai Painting:

• Sohrai Painting is an indigenous mural art deeply embedded in cultural traditions. The term 'Sohrai' is derived from 'soro,' meaning 'to drive with a stick.'
• With roots dating back to the Meso-chalcolithic period (9000-5000 BC), this art form can be traced to ancient times.
• Notably, the Isko rock shelter in Barkagaon, Hazaribagh, showcases rock paintings identical to traditional Sohrai art

Theme and Elements:

• Themes in Sohrai Painting predominantly revolve around natural elements such as forests, rivers, and animals. Tribal (Adivasi) women are the creators of these paintings, utilizing natural substances like charcoal, clay, or soil.
• The primitive manifestation of Sohrai art initially appeared as cave paintings, reflecting its historical evolution.

Geographical Practice:

Primarily practiced by indigenous communities, Sohrai Painting finds expression in the states of Jharkhand, Bihar, Odisha, and West Bengal. The Hazaribagh region in Jharkhand has received a Geographical Indication (GI) tag for this distinctive art form.

Artistic Custodians:

Sohrai Painting serves as the artistic expression of women from tribes like Kurmi, Santal, Munda, Oraon, Agaria, and Ghatwal.

Distinctive Features:

Renowned for vibrant colors, intricate patterns, and symbolic motifs, Sohrai paintings carry a unique visual identity.

Sohrai Festival:

An annual Sohrai festival marks the harvesting season and the onset of winter, celebrating the rich cultural significance of this art form.