Latest news with #HarishJain
News18
11 hours ago
- Business
- News18
Indian Pharma Exports At Risk As Shelf-Life Rule Triggers Stock Destruction Concerns, Losses
A new rule by the CDSCO barring exports of pharmaceutical products with less than 60% shelf life is leading to significant losses A new rule by the Central Drugs Standard Control Organisation (CDSCO) barring exports of pharmaceutical products with less than 60% shelf life is leading to significant losses for the domestic industry, with manufacturers being forced to destroy stocks to comply, The Economic Times reported. In a recent meeting with CDSCO, the industry urged the regulator to revise the rule or consider an alternative solution. Pharma lobby group Federation of Pharma Entrepreneurs (FOPE) also wrote to the regulator this week, calling for a repeal of the regulation introduced last year. FOPE president Harish Jain argued that if importing countries were willing to accept such products, Indian exporters should not face restrictions. In its letter, FOPE noted that the requirement was causing substantial losses due to destruction of stock. Industry executives explained that, for example, if a drug manufactured in August 2025 had an expiry in July 2027, regulators would require a minimum of 60% shelf life at the time of export for the consignment to be cleared. The CDSCO updated its export NOC checklist after reports surfaced that an Indian company had exported unlicensed drug combinations to African nations such as Ghana and Nigeria. Regulatory approval has since become mandatory for all medicines intended for export. Industry experts told ET that the rule should apply only to narcotics, opioid combinations, and other habit-forming drugs, not to all categories of medicines, including vitamins. They said the regulation posed a major challenge, as export consignments are custom-made with importing country details and cannot be diverted to the domestic market, forcing companies to destroy them. A government official told ET that the step was aimed at preventing recurrence of such incidents. The official added that India, known globally as the 'world's pharmacy," could not risk reputational challenges related to the quality of exported drugs. view comments First Published: Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy. Loading comments...
Time of India
18 hours ago
- Business
- Time of India
Stricter shelf life rule a bitter pill to swallow for pharma companies
A new rule by the drug regulator barring exports of any product with less than 60% shelf life is causing huge losses to the domestic pharmaceutical industry with manufacturers being forced to destroy stocks to comply. In a recent meeting with the Central Drugs Standard Control Organisation ( CDSCO ), the industry urged for a revision in the rule or an alternative solution. Pharma lobby group Federation of Pharma Entrepreneurs ( FOPE ) has also written to the regulator this week urging the latter to repeal the rule introduced last year. "Our view is that if the importing country allows it, why should we have an objection," said Harish Jain, president, FOPE. "This is causing substantial losses due to destruction of stock," FOPE said in its letter, a copy of which was seen by ET. Live Events "If the manufacturing date is August 2025 and the expiry is July 2027, the drug regulatory authority wants at the time of exports the consignment should have 60% minimum shelf life remaining. Otherwise, they will not allow export," said a senior industry executive. The CDSCO has updated the export NOC checklist , making regulatory approval mandatory for all medicines destined for exports after reports that an Indian company had been exporting unlicensed combinations of drugs to African nations like Ghana and Nigeria. "We have requested the regulatory authority to make this rule mandatory for narcotic drugs, opioid drug combinations, and other habit forming drugs but not for every medicine, even vitamins," said a second industry executive. "This has become a huge challenge for the industry. The companies have to destroy stocks because the export consignments are custom-made with importing country details and cannot be used in India." A government official said the step was taken to make sure that such incidents do not occur. "India is a world pharmacy and we cannot afford to face reputational challenges, particularly concerning the quality of drugs which are being exported to other countries," he said.
Mint
28-07-2025
- Business
- Mint
Centre to rope in states to enforce drug quality norms
New Delhi: The Drug Controller General of India (DCGI), is set to instruct states and Union territories to identify and take action against drugmakers failing to adhere to Good Manufacturing Practices (GMP), according to two official familiar with the matter. GMP is meant to ensures consistent production and quality control, vital for patient safety, product effectiveness, and preventing fake drugs. A recent revision of Schedule M GMP rules seeks to align India's quality standards with global benchmarks in a bid to boost the country's reputation as a reliable drug producer. All large companies, with revenues exceeding ₹ 250 crore, are implementing GMP while smaller firms received an extension until 31 December to make the necessary upgrades. 'Those who have applied to implement GMP and upgrade their facility have got time till December. Now state governments have to verify the compliance of those companies who have not applied. Now, DCGI may issue some direction to the State/UTs to look into this matter and identify non-compliance firms,' said the official. 'The matter was also discussed sometime back involving officials from Niti Aayog, pharma associations and Central Drugs Standard Control Organization (CDSCO),' the second official said. About 8,500 of India's 10,000 pharma companies are small businesses, concentrated in Maharashtra, Gujarat, Himachal Pradesh, and Andhra Pradesh. Only 2,000 of these MSMEs currently have GMP certification from the World Health Organization. According to government estimates, the Indian pharmaceutical market was valued at an estimated $50 billion in FY 2023-24, with domestic consumption accounting for $23.5 billion. Globally, India's pharmaceutical industry stands as the third largest by volume and the 14th largest by value, being the foremost supplier of generic drugs worldwide, contributing approximately 20% of the global supply. This encompasses the production of around 60,000 generic brands across 60 therapeutic categories. Key segments within this robust industry include generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research & manufacturing, biosimilars, and biologics. In 2023, the government revised Schedule M of the Drugs and Cosmetics Rules, 1945, making new GMP standards mandatory for drug manufacturers. This initially applied to companies with an annual revenue of ₹ 250 crore and above, and has now been extended to MSME drug firms. This was prompted by incidents of contaminated Indian cough syrups leading to child deaths in the Gambia and Uzbekistan two years ago. Harish Jain, President of the Federation of Pharmaceutical Entrepreneurs (FOPE), stated that Micro, Small, and Medium Enterprise (MSME) drug firms that requested an extension from the drug regulator to implement Good Manufacturing Practice (GMP) compliance are actively upgrading their facilities within the agreed timeframe. He added that any firms not seeking an extension are presumed to be already adhering to the GMP protocols. Dr R.V. Asokan, former president of the Indian Medical Association (IMA) said that as the Indian pharma industry began growing exponentially in the last 25 years, the power to approve drugs was delegated from the Central Drug Authority (CDA) to the state drug authorities. Small states like Uttarakhand and Himachal Pradesh benefitted from business-friendly regulations and GMP was not enforced strictly. "Because of lack of infrastructure and human resources quality assurance is less than satisfactory. The deficiencies, due to the lack of GMP regulations may differ from one company to another. These gaps could be around storage, manufacturing, waste management, ventilation and infrastructure at the pharma units,' he added. Queries sent to the health ministry remained unanswered till press time.
