India is cited as the pharmacy of the world and medicines are exported to over 200 countries. However, the drug regulator CDSCO (Central Drugs Standard Control Organization) has recently come up with a new regulation. From this rule, it is clear that any medicine produced in India to export should maintain at least 60 percent of it shelf life.
At first, this may sound like a rule to ensure better quality. But in reality, it has created many problems for pharma companies.
What Does Shelf Life Mean?
Shelf life is the period during which a medicine stays safe and effective for use. For example, if a tablet has a 24-month shelf life, it can be sold for 2 years from the date of manufacturing.
Under the new rule, such a tablet can only be exported in the first 9–10 months. After that, even though the medicine is still safe, it cannot be exported.
How Is the New Rule Affecting Pharma Companies?
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Wastage of Medicines
Many companies are forced to destroy stock because it does not meet the 60% shelf life rule, even though it is still usable. -
Huge Financial Losses
Exporting less means earning less. This hurts not only companies but also employees and the economy. -
Mismatch with Global Rules
Several countries accept medicines with 40–50% shelf life. India’s stricter rule makes it harder to compete in the global market. -
Shortage Risks Abroad
Since India supplies a large share of affordable medicines, stricter export rules may create shortages in other countries.
How Can Companies Cope With This Situation?
The answer is to liaise with a pharma contract manufacturing company. The products produced by these companies assist in quick production, reduction of costs, and just-in-time delivery to ensure that medicines attain the new shelf life requirement. Outsourcing manufacture elaborated that the pharma companies can concentrate on marketing and distribution without having the implications of wastage
Another way to stay profitable is through the monopoly medicine company in India model. Here, entrepreneurs get exclusive rights to sell a product in a specific area. This ensures less competition and better profits, especially in the domestic market.
Why Flexibility Is Important
Experts believe the 60% rule is too rigid. Instead of throwing away medicines that are still effective, the government should make the rule more flexible and match international standards. This will:
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Save money and reduce wastage.
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Keep India’s position strong in the global pharma market.
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Ensure medicines reach patients on time worldwide.
Conclusion
The 60% shelf life rule has become a serious challenge for Indian pharma companies. While it was made to ensure quality, it is causing wastage, losses, and global trade issues.
Still, companies can reduce the impact by:
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Partnering with reliable contract manufacturing pharmaceutical companies for efficient production.
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Exploring domestic growth with monopoly pharma franchises.
A balanced approach is needed—one that protects quality but also supports business and patient needs.
FAQs
Q1. What is shelf life in medicines?
Shelf life is the time during which a medicine remains safe and effective for use.
Q2. What is the new CDSCO shelf life rule?
The rule says exported medicines from India must have at least 60% of their shelf life left at the time of shipping.
Q3. Why is the rule a problem for pharma companies?
Because companies now have to destroy usable medicines, leading to wastage, losses, and export delays.
Q4. How can companies manage this challenge?
By partnering with a pharma contract manufacturing company for faster production and focusing on monopoly pharma franchises in India.
Q5. What is a monopoly medicine company?
It’s a business model where a distributor gets exclusive rights to sell medicines in a particular region, reducing competition.