Piramal Enterprises Ltd (PEL) has received a tax demand notice from the Maharashtra Goods and Services Tax (GST) department for Rs. 1,502 crore, allegedly for short payment and non-payment of tax, interest, and penalties on the sale of its pharma business to Piramal Pharma Limited (PPL). The sale was valued at Rs. 4,487 crore. The GST department considers the transfer of subsidiary companies as a taxable event, which is subject to 18% GST on the full value of the sale, including goodwill. Piramal Enterprises believes the demand is unreasonable and is seeking to challenge the order.

The company’s flagship business is in non-banking finance, retail, and wholesale lending, alternative funds, and life insurance. The tax demand is significant, amounting to 15% of the company’s revenue, but PEL believes it has adequate grounds to defend itself and will take appropriate legal action. The company expects a favorable outcome and has stated that the tax demand will not impact its balance sheet or profit and loss account for the financial year.

The dispute highlights the complexities of India’s indirect tax regime, particularly with regard to the transfer of businesses and the application of GST. The outcome of the case will be closely watched by the business community, which is still grappling with the implications of the GST Act.

Farhat Nasim is a dedicated editor for the Business Section of Medical Dialogues, a prominent online publication, since 2017. She is responsible for covering the latest developments and updates in the pharmaceutical industry, as well as policy, insurance, business, and healthcare. Her areas of expertise also include medical news, health news, pharma news, and healthcare and investment.

Before joining Medical Dialogues, Farhat completed her education from St. Xavier’s College in Ranchi. Her extensive educational background has provided her with a strong foundation in journalism and communication. Her experience in editing and reporting has given her a keen eye for detail and a passion for delivering accurate and engaging content.

As an editor, Farhat is well-versed in the intricacies of the healthcare industry and is committed to providing in-depth analysis and insights to her readers. Her expertise includes staying up-to-date with the latest developments in the pharmaceutical sector, including regulatory changes, new product launches, and market trends. She also closely monitors policy changes, insurance, and industry news to provide comprehensive coverage.

Farhat can be reached at editorial@medicaldialogues.in or at contact number 011-43720751. Her expertise and dedication to journalism make her an essential resource for those seeking reliable and informative content in the rapidly evolving healthcare industry.

India’s contract research and development manufacturing organization (CRDMO) sector is on the cusp of significant growth, with potential to expand seven-fold to $22-25 billion by 2035. The sector, which is currently valued at $35-40 billion, is expected to play a crucial role in the global pharma industry, which is valued at $140-145 billion.

India’s CRDMO sector has gained from global companies’ efforts to diversify their supply chain away from China, following the pandemic and a US bill restricting federal contracts with certain Chinese biotech firms on national security grounds. However, Indian firms are still facing regulatory hurdles, which are hindering their growth.

Companies such as Sai Life Sciences, Piramal Pharma, and Syngene have urged the government to remove regulatory hurdles and grant faster clearance for vital raw material imports. They have called for a more business-friendly policy environment, with a centralized digital single-window clearance system, easy export and import capabilities, and more investment in the sector.

The industry is also facing challenges such as prolonged approval times, demanding regulatory requirements, lack of customs warehouses, and delays in clearing certain raw material imports. The government’s inaction on these issues has hindered India’s CRDMO sector’s growth potential.

Despite the challenges, India’s CRDMO sector has received significant investment, with over $2.86 billion invested in the local biotech industry. Industry leaders are calling for more investment and support to help India become a major hub for contract manufacturing and research and development. With the right policies and investment, India could emerge as a leading player in the global CRDMO sector, providing a major fillip to the country’s economy.

Piramal Pharma Limited’s facility at Turbhe in India has received a Form-483 from the US FDA after a recent General GMP (Good Manufacturing Practice) inspection. The inspection, which took place from February 11th to February 17th, 2025, resulted in 6 observations. While the observations are related to improving procedures and practices, they are not related to data integrity.

A Form-483 is a notification from the FDA to the facility owner, outlining the agency’s observations and requiring a response. The company is preparing a detailed response to the observations, which will be submitted to the agency within the stipulated time frame.

It’s worth noting that the observations are focused on procedural and practice improvements, which suggests that the facility is not in non-compliance with cGMP regulations regarding data integrity. This is a significant development, as it implies that the facility is not at risk of being shut down or having its exports restricted. Instead, the company is required to address the procedure-related issues to ensure compliance and maintain compliance.

The outcome is a positive sign for Piramal Pharma, as it demonstrates the facility’s compliance with cGMP regulations and its commitment to maintaining good manufacturing practices. The company’s prompt response to the observations will likely help to address any concerns and prevent any potential issues in the future. Overall, the brief is a testament to the facility’s commitment to quality and its ability to adapt to regulatory requirements.

The US Food and Drug Administration (FDA) has issued six observations for Piramal Pharma’s Turbhe facility. The facility is known for producing various pharmaceutical products, including generic drugs and active pharmaceutical ingredients (APIs). The observations were issued after an inspection conducted by the FDA from June to August 2022.

According to the FDA’s inspection report, the observations were categorized into two main areas: “Manufacturing Inspections” and “Packaging and Labeling”. The agency highlighted several issues that required immediate action, including:

1. Deviations in cleaning and sanitation: The FDA inspectors found that the facility’s cleaning and sanitation procedures were not consistently followed, which may potentially lead to product contamination.
2. Inadequate sampling and testing: The agency observed that the facility’s sampling and testing procedures for raw materials, in-process materials, and finished products were inadequate, which may impact product quality.
3. Incorrect labeling: The FDA found instances of incorrect labeling, as well as inadequate product labels for some products.
4. Improper storage and handling: The facility was not storing and handling products according to the recommended guidelines, which could lead to degradation or contamination of the products.
5. Inadequate training: The agency noted that the facility’s employees did not receive adequate training on good manufacturing practices (GMPs) and quality control procedures.
6. Inadequate quality control and assurance: The FDA inspectors found that the facility’s quality control and assurance procedures were not being followed, which may impact the quality of the products produced.

As a result of the observations, Piramal Pharma has been given a certain period of time to address the issues and correct the deviations. Failure to do so may result in further action by the FDA, including but not limited to, business suspension or product recall. It is essential for the company to take immediate and sustained corrective actions to ensure the production of high-quality products and maintain compliance with US FDA regulations.

Piramal Pharma has appointed OMD India, part of Omnicom Media Group, as its integrated media agency after a multi-round pitch. OMD India will handle the marketing and media efforts for Piramal Pharma’s portfolio of over-the-counter (OTC) brands, including Lacto Calamine, Little’s, Tetmosol, Polycrol, and Women’s intimate health range. The agency will be responsible for enhancing the brand’s presence, driving consumer engagement, and creating an impact-driven marketing strategy to drive business growth.

OMD India will manage the account out of its Mumbai office, bringing its expertise in media and digital innovation to create a game plan to boost brand salience and drive business growth. Anisha Iyer, CEO of OMD India, noted that the partnership represents a significant opportunity to leverage the agency’s strategic acumen and market intelligence to elevate Piramal’s portfolio of brands to new heights.

This win is a significant milestone for OMD India, building on its recent success, including winning the integrated media mandate for HDFC Life in January 2025. The partnership with Piramal Pharma is expected to further strengthen OMD India’s presence in the market. With this move, Piramal Pharma aims to create a lasting impression on consumers across India and shape a future of sustained growth and impact.