Pharma exporters seek time to comply with only submission for COPP
Regulatory policies must strike a balance between maintaining stringent quality standards and being trade-facilitative, Pharmaceuticals Export Promotion Council of India Director General K. Raja Bhanu said.
COPP or the no-objection certificate CDSCO issues certifies that the manufacturing unit concerned complies with World Health Organisation Good Manufacturing Practices norms.
'Exporters are now burdened with a dual regulatory bottleneck - domestically through CDSCO's NOC/new drug classification delays and internationally due to slower regulatory submissions and approvals abroad, Mr.Bhanu said in a release. Pharmexcil has requested the Ministry and CDSCO to delay implementation of the circular that mandates exclusive online submission of COPP applications via the ONDLS (one nation, one drug licensing) portal.
Seeking a phased rollout with existing processes running in parallel to allow time for exporters to align, the exporters body under the Commerce Ministry said it supported digital integration and modernisation of regulatory frameworks. However, if the mandate is abruptly enforced without a transitional roadmap there is a possibility of a major disruption to the pharmaceutical exports - particularly to Rest of World markets. About 45% of India's pharma exports are to ROW markets.
'Quality and commerce may not always align in the short term, but this balance is the only sustainable path forward - which will be transformative for brand India. While the government rightly aspires to ensure responsible manufacturing, some of the regulatory developments are misperceived by industry players as commercial limitations. The inability to secure timely COPP approvals or NOCs has the potential to push overseas buyers toward alternate suppliers from competing nations, causing irreversible long-term damage to Indian exporters,' Mr. Bhanu said.
Pharmexcil said it has identified additional challenges, including brand India being undermined by premature regulatory alerts, especially those triggered by interim data published on CDSCO's portal regarding domestic samples, many of which are unrelated to export batches. Global regulators interpret these incomplete data sets as red flags, leading to alerts across ROW markets.
Several drugs that have been on Indian pharmacy shelves for years are being newly classified as 'new drugs' based solely on dosage forms (e.g., coated tablets), triggering delays in COPP issuance and drastically increasing export turnaround time, it said.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
India.com
2 minutes ago
- India.com
No Entry For GM Crops, Says New Delhi; India-US Trade Talks Hit A Sacred Wall
New Delhi: Genetically modified (GM) crops will not be crossing India's borders anytime soon, no matter how urgently the United States knocks. As trade negotiations between New Delhi and Washington enter a crucial phase, insiders say one red line is not up for discussion. 'There are things that are not about negotiation. Some things are a matter of principle,' said a senior official close to the development. That principle, sources say, is GM corn and soy. While American negotiators have made agricultural access a central demand, pressing India for a wider entry gate for U.S. farm goods, New Delhi is not blinking, especially on GM imports. Over the years, the issue has mutated from a mere trade disagreement into a symbolic fight over sovereignty, food safety and grassroots politics. The United States Trade Representative (USTR) has repeatedly flagged India's restrictions on GM products, calling them 'non-tariff barriers'. But Indian authorities remain unmoved, largely because of the hardline stance taken by domestic groups closely aligned with the ruling establishment. Last month, the message from Sangh affiliates was if America insists on forcing GM crops into the Indian market, there may be no trade deal at all. Carried in Business Standard, that warning echoed the sentiments of influential groups such as the Bharatiya Kisan Sangh (BKS) and the Swadeshi Jagran Manch (SJM), which have long opposed agricultural concessions to Washington, particularly in sectors like dairy and GM crops. Their argument? Food security. The BKS has often warned that allowing U.S. crops into India, especially without clear labelling or transparency, could sabotage domestic farming ecosystems and compromise health safety standards. On the other hand, the SJM sees this as a direct attack on economic self-reliance. Meanwhile, the clock is ticking. U.S. officials have privately hinted at the urgency of the moment, pointing to a deadline set by President Donald Trump, who is seeking a revival of his trade agenda. Trump has marked August 1 as a red-letter day. If no interim deal is inked by then, India could be hit with reciprocal tariffs, potentially as high as 26 percent. Indian trade negotiators are not indifferent to that pressure. But according to officials involved in the process, the sixth round of talks will only happen in the second half of August after Trump's deadline expires. Any hope for a short-term resolution seems, at best, unrealistic. As one official put it, 'We are not looking at compromise in areas that touch the lives of millions.' In other words, GM corn is off the table. And perhaps, so is the deal, at least for now.
Mint
an hour ago
- Mint
Lenskart receives shareholder nod to raise ₹2,150 crore via IPO: Report
Lenskart IPO: Peyush Bansal-led Indian eyewear company Lenskart has received the approval of its shareholder to raise ₹ 2,150 crore through a fresh issue of shares, reported MoneyControl, citing people aware of the development. According to news report, the company filed its corporate action development with the Ministry of Corporate Affairs' (MCA) Registrar of Companies (RoC), as per the data accessed by TheKredible. The proposal to raise money via an IPO was reportedly given the green light at the company's annual general meeting on 26 July 2025, said the report, adding, the eyewear company is expected to file its draft red herring prospectus (DRHP) with the capital markets regulator, the Securities and Exchange Board of India (Sebi), in the upcoming days. The overall IPO size is expected to be around $1 billion or ₹ 8,500 crore, which includes a secondary offer-for-sale (OFS) component by the existing investors, the report added. Earlier this month, Mint reported that the eyewear company's founder, Peyush Bansal, is looking to buy a 1.5-2% stake in the eyewear retailer worth about $150 million from existing investors ahead of its planned IPO. Peyush is buying small stakes from a bunch of investors. This is being negotiated at around $7-8 billion valuation. Existing investors like TR Capital, Chiratae, Softbank and Kedaara Capital are expected to sell their stake as part of the deal. Over the years, the company has raised $1.08 billion in funding across 19 rounds, including its latest Series I round for $18.2 million on 21 July 2023. It has received investments from various firms, including SoftBank Vision Fund, TPG, and Chiratae Ventures. Kotak Mahindra Capital, Axis Capital, Citi, Morgan Stanley, and Avendus Capital are the company-appointed book-runners for the IPO, which is soon expected to hit Dalal Street. The company was founded in 2010, and since then, it has emerged as one of the biggest players in the Indian eyewear industry. It has 2500 retail outlets across the nation and a presence globally, such as in Singapore and the United Arab Emirates (UAE).
Time of India
2 hours ago
- Time of India
Robust tourism helps excise dept boost revenue by 45% since 2022
Panaji : Goa's excise department has seen a significant jump in revenue, with a 45% increase over the last four financial years. The department raked in Rs 947.9 crore in 2024-25, as against Rs 650 crore in 2021-22. This increase is attributed to robust tourist footfalls and enforcement by the department. Goa's excise collection shot up to Rs 865 crore in 2022-23 due to several measures implemented by the excise department. In 2023-24, the department's revenue increased to Rs 900.2 crore. Goa's excise revenue is largely driven by tourists who either purchase alcohol from retail stores or consume liquor at restaurants and hotels. Alcohol sales are also driven by events in the state. Data shared with the legislative assembly also shows that Rs 4.1 crore is owed to the department by 242 retail outlets, bars and alcohol manufacturers since 2018. Of the 242 defaulters, most are from Tiswadi and Salcete talukas. While some of the licence holders have come forward and cleared their dues, the department has been forced to issue notices to most of the excise licence holders to recover what is owed. Those outlets which have ignored notices and reminders to pay the annual audit fees risk having their licences being cancelledwith the department already proposing to cancel some licences">, said officials. In the Goa budget 2023-24, the excise duty on high-end liquor was reduced and duty on other categories of Indian made foreign liquor (IMFL) was marginally increased to shore up revenues. The department said that while no tax refund or waiver has been granted under the Excise Duty Act, applicants have been offered an adjustment of excise duty only in cases where permits are cancelled and the said excise duty paid for liquor goods in these cancelled permits are adjusted in their future permits.
