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Anti dumping probe on Calcium Carbonate

Calcium Carbonate

India’s Directorate General of Trade Remedies (DGTR) has initiated a probe into the alleged dumping of calcium carbonate filler masterbatch from Vietnam.

This move comes after domestic manufacturers, represented by the Compounds and Masterbatch Manufacturers Association of India (CMMAI) and Masterbatch Manufacturers Association (MMA), filed petitions claiming significant injury to their businesses.

What is Calcium Carbonate Filler Masterbatch?

Calcium carbonate filler masterbatch is a specialized material used in various industries, including the medical sector.

It’s a compound of calcium carbonate, polyethylene resin, and other additives that enhance the physical and chemical properties of medical products.

This material is commonly used in:

  • Blister packaging: To protect medications and medical devices.
  • Individual-wrap packages: For single-dose medications and medical supplies.
  • Pouches: For storing and dispensing medical products.

Why the Investigation?

Domestic manufacturers allege that Vietnam is exporting calcium carbonate filler masterbatch at significantly reduced prices, a practice known as dumping.

This unfair trade practice can harm local industries by:

  • Price Undercutting: Selling products at lower prices than what it costs to produce them.
  • Market Disruption: Flooding the market with cheap imports, making it difficult for domestic producers to compete.

The DGTR’s investigation will determine if these allegations are valid and if the dumping has indeed caused material injury to the Indian industry.

Impact on Indian Industry

The majority of India’s calcium carbonate filler masterbatch production capacity is concentrated in the hands of small-scale and unorganized sector businesses, which are particularly vulnerable to unfair trade practices.

If the investigation confirms dumping, the DGTR may impose anti dumping duties on imports from Vietnam to level the playing field.

This move could provide relief to Indian manufacturers, allowing them to compete fairly and protect domestic jobs.

However, it’s important to note that such measures should be carefully calibrated to avoid unintended consequences, such as higher costs for consumers and potential retaliation from trading partners.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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Delhi Court orders Permanent Injunction in a Trademark case

Trademark

Key Points:

  • Trademark Dispute: SGS Pharmaceuticals’ “Diclozen Relief” found to infringe Laborate Pharmaceuticals’ registered trademark “Labdic Relief.”
  • Packaging Similarity: Delhi Court rules that SGS Pharma’s packaging design closely mimics Laborate Pharma’s, leading to potential consumer confusion.
  • Permanent Injunction: Court issues a permanent injunction, barring SGS Pharma from manufacturing and marketing “Diclozen Relief.”
  • Nominal Damages: SGS Pharma ordered to pay Laborate Pharma nominal damages of Rs 5,00,000.

Delhi Court Orders Permanent Injunction

In a significant legal victory for intellectual property rights, a Delhi District Court has issued a permanent injunction against SGS Pharmaceuticals Pvt. Ltd., compelling the company to cease manufacturing and marketing its pharmaceutical product “Diclozen Relief.”

The court’s decision stems from a trademark infringement lawsuit filed by Laborate Pharmaceuticals India Ltd., alleging that SGS Pharma’s product closely resembles its registered trademark “Labdic Relief” in terms of packaging design and overall presentation.

The Trademark Case

Laborate Pharmaceuticals, a well-established pharmaceutical company operating since 1990, has registered the trademark “Labdic Relief” for its anti-inflammatory medication.

The company has also secured copyright protection for its unique packaging design, which includes the term “Fast Dissolving” and the acronym “FD.”

In 2019, Laborate Pharma discovered that SGS Pharma was marketing “Diclozen Relief,” an analgesic, with strikingly similar packaging and design.

The company argued that SGS Pharma’s product was deliberately designed to imitate its own, with the intent to deceive consumers and capitalize on Laborate Pharma’s established goodwill.

Court’s Decision and Rationale

After careful consideration of the evidence presented by both parties, the court ruled in favor of Laborate Pharma.

Key factors influencing the court’s decision include:

  • Trademark Similarity: The court found that the overall appearance of SGS Pharma’s “Diclozen Relief” packaging was substantially similar to Laborate Pharma’s “Labdic Relief” packaging, potentially leading to consumer confusion.
  • Copyright Infringement: The court determined that SGS Pharma’s packaging design infringed upon Laborate Pharma’s copyrighted design, as it closely imitated the color scheme, font style, and layout.
  • Passing Off: The court concluded that SGS Pharma’s actions constituted passing off, as the company was attempting to trade on Laborate Pharma’s reputation and goodwill.

Implications for Pharmaceutical Industry

The court’s decision underscores the importance of protecting intellectual property rights in the pharmaceutical industry.

It serves as a strong reminder to pharmaceutical companies to safeguard their trademarks and copyrights to prevent unauthorized use and dilution.

By upholding the rights of innovators and protecting consumer interests, the court’s decision has far-reaching implications for the industry as a whole.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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CDSCO to implement stricter regulations for health supplements

Supplements

The supplements industry is set to face tighter regulations as the government takes steps to curb misleading health claims.

A government panel has recommended shifting the oversight of supplements with exaggerated health claims from the Food Safety and Standards Authority of India (FSSAI) to the Central Drugs Standard Control Organisation (CDSCO).

Why the Change?

The move aims to address the growing concern over supplements that make unsubstantiated claims of curing or preventing diseases.

By bringing these products under the purview of the CDSCO, the government intends to ensure stricter scrutiny and accountability.

Key Recommendations of the Expert Panel:

  • Stricter Regulation for Disease Claims: The panel has proposed that claims related to curing, mitigating, or reducing the risk of diseases should be regulated by the CDSCO.
  • FSSAI to Focus on Nutritional Claims: The FSSAI will continue to regulate nutritional and health claims that are already listed under the FSS (Claims and Advertisements) Regulations 2018.
  • Mandatory Label Submission: The panel has recommended that manufacturers submit product labels along with health claims at the time of licensing.

The Need for a Unified Regulatory Framework

The rapid growth of the nutraceutical industry has led to a surge in products with misleading claims.

To address this issue, a high-level committee has been formed to review existing guidelines and develop a comprehensive regulatory framework.

This committee includes representatives from various government agencies, including the Ministry of Health and Family Welfare, the Ministry of Food Processing Industries, and the Department of Pharmaceuticals.

In conclusion, as the government takes steps to strengthen the regulation of supplements, consumers can expect to see more accurate and truthful labeling.

This move will not only protect public health but also ensure fair competition in the industry.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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Govt upholds ceiling price fixation for Azathioprine 50 mg

Ceiling price

RPG Life Sciences, a prominent pharmaceutical company based in Mumbai, has recently faced a setback in its legal battle against the National Pharmaceutical Pricing Authority (NPPA).

The Department of Pharmaceuticals (DoP) has dismissed the company’s appeal to overturn the ceiling price imposed on its immunosuppressant drug, azathioprine 50 mg.

NPPA’s Decision and RPG’s Appeal

On January 6, 2023, the NPPA implemented a ceiling price of Rs. 10.04 per tablet for azathioprine 50 mg.

This decision was later revised to Rs. 11.26 per tablet on May 15, 2024.

Dissatisfied with this price cap, RPG Life Sciences filed a review application on February 1, 2023, arguing that the NPPA had made errors in its calculations.

The Core of the Dispute

The primary contention of RPG Life Sciences was the inclusion of its discontinued 10’s pack size in the NPPA’s calculations.

The company argued that only the continuing 20’s pack should be considered for price determination.

However, the NPPA countered this claim, citing the Pharmatrac data of July 2022, which indicated that both pack sizes were available in the market at that time.

Related news: Clotrimazole Cream Price Dispute: Govt upholds NPPA’s Ceiling Price

DoP Upholds NPPA’s Decision

After a thorough review of the case, the DoP sided with the NPPA’s decision.

The department acknowledged that both pack sizes were indeed available in the market in July 2022 and were accurately captured by the Pharmatrac data.

As a result, the DoP concluded that the NPPA’s methodology for calculating the ceiling price was appropriate and upheld the original decision.

Implications for the Pharmaceutical Industry

This ruling has significant implications for the pharmaceutical industry in India.

It reinforces the NPPA’s authority to regulate drug prices and highlights the importance of accurate data in price determination.

The decision also emphasizes the need for pharmaceutical companies to comply with regulatory guidelines and to provide affordable medicines to patients.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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CDSCO Nod granted to Conduct Clinical Trial of Ruxolitinib cream

Clinical Trial

Key Points:

Intas Pharmaceutical has secured the green light from the CDSCO to initiate Phase III clinical trial for its innovative Ruxolitinib cream 1.5% w/w.

This pivotal development marks a significant step forward in the potential treatment of skin conditions.

The Road ahead

While the approval is a major milestone, Intas Pharmaceutical must adhere to specific conditions outlined by the CDSCO.

These conditions include:

  • Revised Clinical Trial Protocol: The company must submit a revised clinical trial protocol that incorporates detailed information about the study centers where the trials will be conducted.
  • Government Hospital Participation: A minimum of 50% of the study sites must be government hospitals.
  • Age Criteria: The inclusion criteria for participants must be uniformly set at 18 years and above.
  • Equivalence Study Documentation: The company must provide a comprehensive document detailing the rationale for the equivalence study and the specific study design.

Ruxolitinib: A Powerful Drug

Ruxolitinib, a potent Janus kinase (JAK) inhibitor, has demonstrated efficacy in treating various blood disorders.

By inhibiting the JAK1 and JAK2 protein kinases, Ruxolitinib disrupts specific cellular signaling pathways involved in disease progression.

Potential Benefits of Ruxolitinib Cream

The topical formulation of Ruxolitinib holds promise for the treatment of skin conditions.

While specific indications for the cream are yet to be fully determined, it is anticipated to offer relief for patients suffering from inflammatory skin disorders.

As Intas Pharmaceutical advances its Phase III clinical trial, the medical community eagerly awaits the potential benefits that Ruxolitinib cream may bring to patients.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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No provision for separate license for Pharma marketers

Pharma marketers

A recent demand from the newly formed Association of Indian Pharmaceutical Progressive Entrepreneurs (AIPPE) in Tamil Nadu for a separate license for pharma marketers has been met with a firm “no” from the Tamil Nadu State Drug Controller, MN Sridhar.

Sridhar clarified that the Drugs and Cosmetics Act doesn’t currently provide for separate licenses for marketing companies.

Pharma marketers are currently operating under wholesale licenses issued in Form 20B and 21B.

These licenses, while sufficient for their operations, don’t provide the specific recognition they seek.

The AIPPE’s Plea

The AIPPE, representing small-scale pharma manufacturers and pharma marketers, argues that they should have a distinct identity and license.

They point out that they market their own brands, unlike distributors who handle a wider range of products.

The association has written to both the central and state governments, requesting an amendment to the Drugs and Cosmetics Act to accommodate their demand.

Drug Controller’s Stance

While the drug controller understands the association’s concerns, he maintains that the current licensing system is adequate.

He plans to hold a meeting with wholesalers to clarify the purpose of each license type.

A New Era for Pharma Marketers in Tamil Nadu

The formation of AIPPE marks a new chapter for pharma marketers in Tamil Nadu.

The association aims to address various challenges faced by its members, including education, policy updates, and business development.

By uniting marketers across the state, AIPPE hopes to strengthen their collective voice and influence policy decisions.

Jayachandran, the association’s president, has plans to expand AIPPE’s reach to other states and establish a pan-India presence.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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Important short notes for Industry and Regulators

Important short notes for Regulators and Industry (Pharmaceuticals, Medical Devices, Cosmetics, Homoeopathy, Blood Centres etc.)

Updating on daily basis

Note: 08

Supreme Court Judgment :

Case: Rakesh Kumar and 25 Other Accused.

1. Punjab and Haryana High Court have given relaxation in NDPS case against many (25) offenders who have been convicted by the lower district court.

2. The High Court ruled that if a psychotropic drug is manufactured by a licensed manufacturer, it does not constitute a violation of the NDPS Act.

3. Only a case under the Drugs and Cosmetics Act, 1940, should be filed in such instances.

4. The Punjab Government filed an appeal with the Supreme Court against the High Court's order dated January 29, 2018.

5.On December 3, 2018, the Supreme Court issued a judgment against the accused in the NDPS case.

6. The Supreme Court overturned the Punjab and Haryana High Court's orders and directed the courts to take custody of the accused.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 07

Diphenoxylate :

1. An official drug listed in the Indian Pharmacopeia (IP).

2. Available in tablets dosage forms.

3. Notified as a "Manufactured Drug" under the NDPS Act (serial no. 58 vide notification S.O. no. 826 (E) dated 14.11.1985).

4. Only allowed with Atropine sulfate with a dose of at least one percent of the dose of Diphenoxylate.

5. This drug is included in Schedule H1 of the Drugs Act .(serial number 23).

6.A Drugs Sale License (Retail/Wholesale) under the Drugs Act is mandatory to sell this drug.

7. Licensee must maintain sale/purchase records. Failure to do so is a contravention of Rule 65A of the NDPS Act, 1985.

8. Unlicensed manufacturing, stocking, and sale of formulations are offenses under the NDPS Act, 1985, and Drugs Act.

9.Offence Severity Depends on the quantity :
Small quantity : 2 grams
Commercial quantity : 50 grams.
(vide notification S.O. no. 1055 (E) dated 19.10.2001).

10 NRx" labeling is not mandatory .

11.Dose available is 2.5 mg / 0.025 mg.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 06

Notification NDPS : Small and commercial quantity.

1055(E) dated 19 Oct 2001 under NDPS Act 1985.

Total 239 Drugs( ND+PS)

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 05

Different between cream and ointments :

Example :

1. Fusidic acid cream IP.

2. Firm can't claim Fusidic acid Ointment IP.

3. SLA can't grant permission Fusidic acid Ointment IP.

4. The word "ointment" is not recognized in the case of Fusidic in IP and BP both.

5. Ointments typically have a higher oil content than creams.

6. Creams generally have a higher water content than ointments.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 04

As per rule 7 of MDR-2017.

Standards for medical devices in India are as under:

BIS.
ISO.
IEC.
IP/BP/USP, etc
IH

ASTEM (draft)

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 03

PG : Propylene Glycol

1.All Allopathic manufacturers must conduct comprehensive testing of Propylene Glycol (PG) in their formulations as per the pharmacopeia standards (IP/BP/USP).

2. To test PG, gas chromatography (GC) is required.

3. Every batch of PG must undergo testing, and the test report should include a graphical representation.

4. Proper storage of PG is also crucial.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 02

Banned drug :

  • Aceclofenac SR and Paracetamol are banned under section 26A of the drug act.
  • Aceclofenac + Paracetamol is not banned.

 

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 01

1. Notification no. S.O. 1577 (E) dated 28th March 2024.

2.Now, Sections 27(d) and 27–A(ii) have been added to the list of compoundable offenses under the Drugs Act.

3. W.e.f 31st December 2024

4. The offenses committed prior to 31st December 2024 are not compoundable.

5.Decriminalised & only fine .

6.The provision for Compounding of offense Section 28 & Section 28A of the D&C Act was already there, which was inserted w.e.f. 2009.

7. Applicable in the cases of medical devices, cosmetics, homeopathic medicines, disinfectants, blood centers, etc.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

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Deadly reactor explosion at Pharma Plant in Andhra Pradesh

Explosion

A catastrophic reactor explosion rocked Metrochem Pharma Company’s facility in Parawada, Anakapalli district, Andhra Pradesh, on Saturday night around 9:30 PM.

The incident triggered immediate panic, forcing workers to evacuate the premises.

Local emergency services were swiftly dispatched to the scene.

Key Details of the Explosion

  • Cause of the Explosion: A severe pipe leakage in the reactor system is believed to have triggered the explosion.
  • Emergency Response: Local fire crews arrived promptly and successfully extinguished the fire that erupted following the blast.
  • Casualties: While initial reports from CPM leaders suggested four casualties, official confirmation from police and company management is still awaited.

Worker Safety and Investigation

  • Safe Evacuation: All workers present at the time of the explosion were able to evacuate safely.
  • Police Investigation: The Parawada police have launched a thorough investigation to determine the exact cause of the pipe leakage and the subsequent explosion.

Worker’s Union Demands

The CPM workers’ association has demanded transparency from the company owners, urging them to disclose the names of B-shift workers and ensure adequate compensation for those who may have been injured in the incident.

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Drug recall: Dr Reddy’s recalls Cinacalcet Tablets due to impurity Concerns

Drug recall

Dr. Reddy’s Laboratories, a leading global pharmaceutical company, has initiated a voluntary drug recall of over 331,000 bottles of Cinacalcet tablets in the United States.

This drug recall is being undertaken due to the detection of an impurity, N-nitroso Cinacalcet, which exceeds the US Food and Drug Administration’s (USFDA) recommended interim limit.

Why the Drug Recall?

The USFDA has classified this drug recall as a Class II drug recall, indicating a potential for temporary or medically reversible adverse health consequences.

The affected lots of Cinacalcet tablets were manufactured in India and distributed across various US states.

What is Cinacalcet?

Cinacalcet is a medication primarily used to treat:

  • Hyperparathyroidism: A condition where the parathyroid glands produce excessive amounts of parathyroid hormone (PTH).
  • Secondary Hyperparathyroidism: A complication often associated with chronic kidney disease.

Impact on Patients

Patients currently taking Cinacalcet tablets should consult with their healthcare provider to discuss alternative treatment options.

It’s crucial to follow medical advice and avoid discontinuing medication abruptly without consulting a healthcare professional.

Dr. Reddy’s and the US Market

Dr. Reddy’s Laboratories has a significant presence in the US generic drug market, which was valued at approximately USD 115.2 billion in 2019.

The company’s operations in the US are conducted through its subsidiary, Dr. Reddy’s Laboratories, Inc., based in New Jersey.

The Future of Indian Pharmaceuticals

India’s pharmaceutical industry is a global powerhouse, ranking third by volume and fourteenth by value.

It’s essential for Indian pharmaceutical companies to prioritize quality and adhere to stringent regulatory standards to maintain their position in the global market.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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Indian Pharma Industry to face New GMP Regulations Compliance

GMP Regulations

Indian pharmaceutical manufacturing sector is on the brink of a significant upheaval as stringent Good Manufacturing Practices regulations (GMP regulations) are set to take effect.

This impending change could force a large number of small and medium-sized pharmaceutical units to be in trouble, potentially disrupting the supply chain and impacting the affordability of essential medicines.

Upcoming GMP regulations

The upcoming GMP regulations, which are designed to align Indian pharmaceutical manufacturing with global standards, are expected to impact around 40% of small and medium-sized pharmaceutical units.

These businesses, which contribute significantly to the sector, may struggle to meet the stringent quality and safety standards required by the new regulations.

The Financial Burden on Small-Scale Manufacturers

One of the major challenges facing small-scale manufacturers is the substantial financial investment required to upgrade their facilities and implement the necessary quality control systems.

The cost of upgrading equipment, infrastructure, and technology can be prohibitive for many businesses, especially those with limited resources.

The Skill Gap and Workforce Challenges

Another significant hurdle is the shortage of skilled personnel in the pharmaceutical industry.

The high attrition rate of 25-30% exacerbates this problem, making it difficult for manufacturers to find and retain qualified employees.

Government Intervention and Industry Support

To address these challenges, the government has introduced various initiatives, including the revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS), to provide financial support to manufacturers.

Additionally, industry associations like the Indian Drugs Manufacturers Association (IDMA) and the Confederation of Indian Pharmaceutical Industry (CIPI) are working with the government to extend the implementation deadline and provide training and technical assistance to small-scale manufacturers.

A Delicate Balancing Act

While the government aims to improve the quality and safety of Indian pharmaceutical products, it must also consider the impact of these regulations on the industry’s sustainability.

Striking a balance between stringent regulations and supporting small-scale manufacturers will be crucial to ensuring the long-term health of India’s pharmaceutical sector.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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