Defining a Scheduled Formulation
What is a Scheduled Formulation in Pharma?
In the pharmaceutical industry, one of the most important regulatory distinctions we often come across is between scheduled and non-scheduled formulations. While it may sound technical, the meaning has a direct impact on both patients and manufacturers — especially in India where affordability and access to essential medicines are national priorities.
Defining a Scheduled Formulation
A scheduled formulation refers to any pharmaceutical formulation that is included in the First Schedule of the Drugs (Prices Control) Order (DPCO), 2013, as notified by the Government of India.
These could be generic versions or branded medicines, but the condition is simple: they must contain a bulk drugspecified in the schedule. In other words, if a drug is part of this list, then every brand that manufactures it — irrespective of the label — falls under the same regulatory framework.
Why the Distinction Matters
The key regulatory authority here is the National Pharmaceutical Pricing Authority (NPPA). For scheduled formulations:
- A ceiling price is fixed by NPPA.
- Manufacturers cannot sell above this price.
- Prices are periodically revised to balance affordability and sustainability.
- Retail pricing is strictly monitored and enforced by law.
The backbone of this system is the National List of Essential Medicines (NLEM). Medicines included in the NLEM are considered critical for public health, and therefore, their prices are controlled to ensure that they remain accessible to patients who need them the most.
Scheduled vs. Non-Scheduled Formulations
To simplify:
- Scheduled formulations = Price controlled, ceiling price enforced, linked to NLEM.
- Non-scheduled formulations = Not under direct price control, but annual price increase is capped at 10%.
This distinction ensures that essential drugs — like those for diabetes, hypertension, antibiotics, and other public health needs — remain affordable, while giving manufacturers room to innovate in areas outside of the scheduled list.
Why This System Exists
The logic is simple: healthcare is not just a market, it’s a responsibility. Without price regulation, life-saving medicines could easily become unaffordable for a large part of the population. Scheduled formulations are the government’s way of ensuring that there is a balance — companies can operate sustainably, but patients are never priced out of essential care.
Final Thoughts
For us in the pharma space, understanding the difference between scheduled and non-scheduled formulations is more than a compliance exercise — it is about aligning with a vision of accessible, equitable healthcare.
At Bioaltus Pharmaceuticals Pvt. Ltd., we see it as a reminder of why we exist in the first place: not just to manufacture medicines, but to make sure those medicines reach the people who need them, at prices they can afford.
