MSME Pharma units get breather as govt extends Schedule M deadline

Pharma cos with turnover of Rs 250 cr or less can submit an application to the central drugs regulator for one one-year extension

The Ministry of Health and Family Welfare (MoHFW) on Saturday issued a draft notification granting a one-year extension for small and medium-sized pharmaceutical companies (with an annual turnover of less than Rs 250 crore) to upgrade their facilities as per the revised Schedule M of the Drugs and Cosmetic Act.

 

Schedule M, which sets quality standards and good manufacturing practices (GMP) for pharmaceutical companies, was notified by the health ministry in January last year and came into effect on January 1, 2025.

 

Initially, pharmaceutical companies with an annual turnover exceeding Rs 250 crore were given six months to comply with the revised Schedule M norms, while those with a turnover of Rs 250 crore or less were provided a 12-month deadline.

   

The draft notification proposes that micro, small, and medium pharma units will now have three months to register with the Central Drug Standards Control Organisation (CDSCO) and submit their upgradation plans. Following registration, these units will be granted a 12-month extension until December 31, 2025.

 

“After three months, an audit of these facilities will be conducted, and action will be taken if the committed upgradation is not being implemented,” the health ministry stated in a note.

 

The draft notification will remain open for public objections and suggestions for seven days from its publication date.

 

Industry challenges and extension rationale

The decision to extend the deadline follows representations from pharma bodies highlighting challenges faced by small and medium-sized units in adhering to the revised GMP norms.

 

Several industry associations, including the RSS-affiliated Laghu Udyog Bharati (LUB), the Federation of Healthcare Professionals (FOPE), and various state drug manufacturing associations representing the MSME pharma sector, had requested an extension.

 

Industry experts pointed to the financial burden of procuring machinery and upgrading infrastructure as significant hurdles preventing timely compliance. “The main reasons for seeking an extension were the need to arrange finances and more time for implementing the required changes,” an expert explained.

 

Reactions and implications

Rajesh Gupta, all-India head of LUB and state president of the Himachal Pradesh Drug Manufacturers Association, expressed gratitude to the government for granting the conditional extension.

 

India has around 10,500 pharmaceutical units, of which 8,500 belong to the MSME sector. Approximately 2,000 MSME units currently hold WHO-GMP certification. Experts believe the extension will prevent many units from closure due to non-compliance and provide them with additional time to upgrade.

 

“Companies can submit a proper schedule to the government, and this extension allows more time to complete the upgradation process,” a senior official from the Indian Drugs Manufacturers Association (IDMA) noted.

 

Progress in GMP implementation

The health ministry reported progress in GMP implementation among MSME units, citing audits conducted by the CDSCO. The regulatory body has inspected over 800 manufacturing units and 252 public testing laboratories to date.

 

“The observations from audited units and feedback from stakeholders indicate significant improvement in GMP standards among MSMEs,” the ministry added.