LATEST ARTICLES

USFDA approval granted for the drug for the treatment of Migraine

Migraine

Lupin Limited (Lupin), a leading global pharmaceutical company, has received a significant boost in its mission to expand access to affordable medications for the treatment of epilepsy and migraine.

The US Food and Drug Administration (USFDA) has approved Lupin’s Abbreviated New Drug Application (ANDA) for topiramate extended-release capsules in four strengths: 25 mg, 50 mg, 100 mg, and 200 mg.

This approval paves the way for Lupin to launch a generic equivalent of Trokendi XR extended-release capsules, manufactured by Supernus Pharmaceuticals, Inc., offering patients and healthcare providers a more cost-effective treatment option.

Broader Treatment Options for Epilepsy and Migraines

Topiramate extended-release capsules are a versatile medication used for two primary purposes:

  • Monotherapy for Epilepsy: This medication can be used as the initial single treatment for partial-onset or primary generalized tonic-clonic seizures in patients aged 6 and above.
  • Migraine Prevention: Topiramate can also be a valuable tool in preventing migraine headaches.

With the availability of a generic alternative, patients struggling with epilepsy or migraines may benefit from increased affordability and potentially wider insurance coverage.

Market Potential

According to IQVIA MAT data from May 2024, Trokendi XR held an impressive market share, with estimated annual sales reaching $253 million in the US alone.

This signifies a substantial demand for topiramate extended-release capsules. By introducing a high-quality generic version, Lupin aims to make this treatment more accessible to a wider population.

Lupin’s dedication to innovation extends beyond just this generic approval.

The company, headquartered in Mumbai, India, has established itself as a transnational pharmaceutical powerhouse.

They develop and market a comprehensive range of branded and generic medications, including biotechnology products and active pharmaceutical ingredients (APIs).

Their reach extends to over 100 markets across the globe, encompassing the US, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

This USFDA approval for Lupin’s topiramate extended-release capsules represents a significant step forward in broadening treatment options for patients with epilepsy and migraines, while aligning with Lupin’s commitment to providing high-quality, affordable medications worldwide.

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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USFDA grants VAI classification to Cipla at Maharashtra

USFDA

Cipla Ltd. a leading global pharmaceutical company, has received a positive outcome following a recent inspection by the United States Food and Drug Administration (USFDA) at its manufacturing facility located in Kurkumbh, Maharashtra, India.

Voluntary Action Indicated (VAI)

In a filing with the Bombay Stock Exchange (BSE), Cipla announced that the USFDA classified the inspection as a Voluntary Action Indicated (VAI).

This designation signifies that while the USFDA may have identified certain areas for improvement, the agency deems them non-critical and does not plan to recommend any regulatory or administrative action against the company.

Addressing Observations for Continued Compliance

Earlier reports indicated that Cipla received one Form 483, a document issued by the USFDA to communicate potential observations during an inspection.

The company has assured investors and stakeholders that it is actively working to address the observation and will submit a comprehensive response to the USFDA within the stipulated timeframe.

About Cipla

Founded in 1935, Cipla is a well-established pharmaceutical company with a strong focus on:

  • Agile and Sustainable Growth: The company prioritizes responsible business practices while achieving consistent growth.
  • Complex Generics Expertise: Cipla holds a leading position in developing and manufacturing complex generic drugs.
  • Strategic Market Focus: The company has a deep presence in key markets like India, South Africa, North America, and other regulated and emerging regions.
  • Robust Product Portfolio: Cipla offers a diverse range of products across therapeutic segments like respiratory, antivirals, urology, cardiology, and more.
  • Manufacturing Excellence: With 47 manufacturing sites globally, Cipla utilizes cutting-edge technology to produce over 50 dosage forms and 1500+ products, catering to over 80 markets worldwide.

This positive outcome from the USFDA inspection reinforces Cipla’s commitment to maintaining the highest standards of quality and compliance in its manufacturing practices.

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Stricter Regulations on Schedule G Drug Ads in India

Schedule G

Public health authorities in India are taking a crucial step towards ensuring medication safety with respect to Stricter Regulations on Schedule G Drug Ads.

The Union health ministry has proposed a draft notification vide GSR No. 375 dt 10-07-2024 that aims to prohibit advertisements of Schedule G drugs without prior approval from the Central Government.

What are Schedule G Drugs?

Schedule G is a designated list within the Drugs and Cosmetics Act, that categorizes medications requiring special precautions due to their potential for misuse or serious side effects.

These drugs often necessitate close medical supervision for safe and effective use.

Here’s a breakdown of the proposed regulation:

  • Targeted Drugs: The new rule applies to a broad range of medications listed under Schedule G, including:
    • Anti-diabetic formulations: This includes medications containing metformin, a cornerstone treatment for type 2 diabetes.
    • Insulin: All forms of insulin, a critical hormone therapy for managing diabetes.
    • Oncology drugs: This encompasses various medications used for cancer treatment, such as chemotherapy drugs.
    • Other Schedule G medications: The list also includes specific antibiotics, anticonvulsants, and antihistamines.

Why the Regulation?

The current regulations only restrict advertisements for Schedule H, H1, and X drugs. This gap allowed unrestricted promotion of Schedule G medications, potentially leading to:

  • Self-medication: Unaware patients might self-medicate with Schedule G drugs, causing dangerous interactions or improper use.
  • Misinformation: Unregulated advertisements could mislead the public about the safety and efficacy of these medications.

Public Participation and Review Process

The Ministry has invited public feedback on the draft notification.

This ensures transparency and allows stakeholders to voice concerns before finalization. Here’s what you can do:

  • Review the proposal: The Ministry will publish the draft notification in the Gazette of India. You can access it and understand the specifics of the proposed regulation.
  • Submit suggestions: If you have any objections or suggestions regarding the draft, you can submit them within 45 days of the notification’s publication.

Expected Benefits

This proposed regulation is expected to:

  • Enhance medication safety: By restricting advertisements, patients are more likely to consult doctors before using Schedule G drugs, reducing risks associated with self-medication.
  • Promote informed decision-making: With limited unregulated advertising, patients can rely on healthcare professionals for guidance on appropriate medication use.

A Step Forward in Patient Safety

The proposed regulation on Schedule G drug advertisements signifies the government’s commitment to safeguarding public health.

By ensuring stricter oversight and promoting responsible medication use, this initiative can contribute to improved patient outcomes in India.

Note: This article is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional for diagnosis and treatment recommendations.

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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Gist of the draft notification: Compounding of Offences under the Drugs and Cosmetics Act

Compounding of Offences

Govt of India has issued a draft notification vide GSR No. 374 dated 10-07-2024 regarding the Compounding of Offences under the Drugs and Cosmetics Act 1940.

These rules may be called as Drugs and Cosmetics (Compounding of Offences) Rules, 2023,

Brief procedure for compounding of offences is as under:

Applying for Compounding

  • Applicant can apply for compounding before or after legal proceedings begin.
  • Use Form-1 (specified in the rules) along with relevant information and documents.
  • Submit the application to the compounding authority.

Processing the Application

  • The compounding authority will request a report from the reporting authority about the offence.
  • The reporting authority has one month to respond (with extensions possible).
  • The compounding authority will review the application and the report:
    • They may approve the application and set a compounding fee.
    • They may reject the application, but only after giving the applicant a chance to be heard and providing reasons for rejection.
  • Applicant will receive a copy of the order (approval or rejection).

If Approved

  • Applicant have 30 days to pay the compounding fee.
  • Proof of payment must be submitted to the compounding authority.
  • The compounding fee is non-refundable (except in rare cases).
  • Approval for compounding is not guaranteed.

Immunity from Prosecution

  • The compounding authority may grant the applicant immunity from prosecution if:
    • Applicant cooperates with the proceedings.
    • Applicant makes a full and truthful disclosure of facts.
  • This immunity can be subject to conditions.

Withdrawing Immunity

  • Immunity can be withdrawn if:
    • Applicant fails to pay the compounding fee on time.
    • Applicant violates any conditions of immunity.
    • Applicant conceals information or provide false evidence during the process.
  • If immunity is withdrawn, the applicant can be prosecuted for the original offence or any related offences.

Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


Compounding Of Offence Under Jan Vishwas Act

New Amendments to Section 32B of the Drugs and Cosmetics Act, 1940

Banned Drugs

Blood Bank / Centre

Cosmetics

COTPA

DPCO / NPPA

Drug Rules

Drugs Act

DMROA

EC Act

General

Homoeopathic

Hospital – RMI

Medical Devices

NDPS Act

New Drugs

Testing Laboratories

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Govt Considers Price Control on Nutraceuticals in India

Nutraceuticals

The Indian government is exploring ways to make essential health supplements, nutraceuticals more accessible to consumers.

A recently formed panel is evaluating the possibility of bringing nutraceuticals under price control, a move aimed at curbing the rising costs of these products often sold over-the-counter (OTC).

Current Regulatory Landscape: FSSAI Holds the Reins

Currently, nutraceuticals fall under the purview of the Food Safety and Standards Authority of India (FSSAI).

These products, which encompass vitamins, minerals, probiotics, and health drinks, are categorized as food supplements and are not subject to price regulations unlike prescription drugs.

Industry Under Fire: Exorbitant Prices and Misleading Marketing

According to government sources, pharmaceutical companies have been exploiting this regulatory gap.

They’ve been observed using high-cost Active Pharmaceutical Ingredients (APIs) typically used in prescription medications to manufacture nutraceuticals.

By adding fillers or diluents, they convert these expensive ingredients into over-the-counter supplements and then mark them up significantly.

This practice, coupled with aggressive marketing strategies, has led to a situation where consumers end up paying a premium for what are essentially lower-dose versions of prescription drugs.

A Booming Market: Need for Regulation

The Indian nutraceutical market is projected to reach a staggering $18 billion by 2025, a sharp increase from $4 billion in 2020.

This rapid growth highlights the increasing demand for these products but also underscores the need for stricter regulations to ensure affordability and prevent consumer exploitation.

A Collaborative Effort: Bringing Stakeholders Together

A high-level committee established earlier this year is actively seeking solutions to propose a new regulatory framework for nutraceuticals, including potential price control measures.

Committee members:

  • Senior officials from the Ministry of Health and Family Welfare,
  • Department of Pharmaceuticals,
  • Ministry of Food Processing Industries,
  • FSSAI,
  • Drugs Controller General of India (DCGI),
  • Indian Council of Medical Research (ICMR), and
  • Directorate General of Health Services,

The Road Ahead: Ensuring Transparency and Consumer Protection

The government’s initiative aims to address the concerns surrounding the pricing and marketing practices within the nutraceutical industry.

By establishing price controls, the government hopes to make these essential health supplements more accessible to a wider segment of the population.

Additionally, the proposed framework is likely to address issues related to interchangeable use of ingredients between pharmaceutical and nutraceutical products, promoting greater transparency and protecting consumer interests.

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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Maharashtra FDA conducts raids at three different locations in Vasai

Maharashtra FDA

The Maharashtra Food and Drug Administration (Maharashtra FDA) conducted a successful raid on July 10th, 2024, uncovering a major case of unlicensed Ayurvedic drug manufacturing.

The operation, spanning three locations in Vasai, District Palghar, targeted M/s Gaharwar Pharma Products Pvt. Ltd.

Unlicensed Manufacturing of Ayurvedic Drugs:

  • The company held a license for Ayurvedic drug production in Haryana, but investigations revealed actual manufacturing happening at the Vasai facility without a proper license.
  • Authorities suspect the Haryana license was surrendered in May 2024, yet production continued illegally at Vasai.

Dubious Distribution Network:

  • The manufactured drugs were supposedly intended for sale to Onkar Pharma in Jalandhar, Punjab. However, this company also operated from Vasai, raising concerns about distribution practices.
  • Additionally, some seized drugs displayed a manufacturing address of Gaharwar Pharma Pvt. Ltd., Navghar Vasai, with a production date of January 2024. This facility previously belonged to Rushabh Medicines, whose license was revoked in 2022.

Significant Seizure and Ongoing Investigation:

  • The Maharashtra FDA confiscated Ayurvedic drugs, raw materials, machinery, packaging materials, labels, and pouches with an estimated value of ₹1.41 crore.
  • This raid follows similar actions taken in March 2024 and 2021 against the company’s sister concern, Rushabh Medicines. Violations included allopathic drugs found in Ayurvedic medicines, leading to legal action and license cancellation.

Officials Involved in the Raid:

  • The operation involved Drugs Inspectors Yogendra Pol, Nitin Aher, and Kailash Khapekar from Palghar and Thane, supported by Assistant Commissioners and Drug Inspectors from Thane, Palghar, and Greater Mumbai.
  • Additional support came from VR Ravi, Assistant Commissioner (IB Mumbai), and Shashikant Yadav, Drugs Inspector (IB Mumbai).

Maharashtra FDA Commissioner Leads the Initiative:

  • The raid was conducted under the guidance of Maharashtra FDA Commissioner Abhimanyu Kale, Dr. Rahul Khade (Joint Commissioner, FDA Vigilance), Narendra Supe (Joint Commissioner, FDA Thane), and Vijay Jadhav (Joint Commissioner, FDA Greater Mumbai).

The Takeaway:

This significant raid highlights the Maharashtra FDA’s commitment to ensuring public safety and adherence to regulations in the Ayurvedic drug manufacturing industry.

Further investigation is underway, with potential legal action against the manufacturer upon completion.

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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Telangana DCA seizes illegally stocked and overpriced medicines

Telangana DCA

The Telangana Drugs Control Administration (TDCA), in a swift and decisive action, has unearthed two major violations in the pharmaceutical sector regarding illegally stocked and overpriced medicines.

Let’s delve deeper into these important developments.

Illegal Sale of Cardiac Stimulants to Bodybuilders:

Unethical Practice Exposed:

In a joint raid on July 10th, 2024, the Telangana DCA, along with the Commissioner’s Task Force and Market Police Station staff, seized a significant quantity of Termin Injections (Mephentermine Sulphate Injection) from MD. Khasim in Secunderabad.

Misuse of Prescription Drugs:

These medicines, meant to treat low blood pressure during surgery, was being illegally sold to gym-goers for bodybuilding purposes.

This misuse can lead to serious health risks, including psychosis and cardiovascular complications.

Importance of Regulations:

The illegal stocking and distribution of prescription drugs like Mephentermine Sulphate Injection is a punishable offense under the Drugs and Cosmetics Act, attracting imprisonment of up to five years.

Overpriced Antifungal Medicines Seized:

Protecting Consumers:

In a separate incident, the Telangana DCA seized stocks of ‘CANDIFACE-200 Capsules‘ (Itraconazole Capsules 200 mg) in Nagole Village due to excessive pricing.

Price Control Measures:

Itraconazole falls under the Drugs (Prices Control) Order, 2013, mandating a “ceiling price” set by the National Pharmaceutical Pricing Authority (NPPA).

Violation Exposed:

The MRP of ‘CANDIFACE-200 Capsules‘ was Rs. 275/- for 10 capsules, exceeding the permissible limit of Rs. 24.77/- per capsule (including GST).

This translates to an overcharge of Rs. 27.30 per 10 capsules.

Taking Action and Ensuring Accountability:

Officials Involved:

For the Mephentermine case:

B Govind Singh (Drugs Inspector, Secunderabad),

G. Anil (Drugs Inspector, Malakpet).

For the Itraconazole case:

Dr B. Lakshmi Narayana (Drugs Inspector, Uppal),

B Praveen (Drugs Inspector, Shameerpet)

Future Course of Action:

The authorities will continue their investigations and take necessary legal actions against all those involved in these violations.

These raids by the Telangana DCA highlight the importance of robust regulatory measures in the pharmaceutical sector.

They not only safeguard consumer rights by ensuring access to affordable medicines but also prevent the misuse of prescription drugs that can pose serious health risks.

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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USFDA approval granted for this chronic heart failure treatment drug

USFDA approval

Zydus Lifesciences Ltd. announced a significant development for patients battling chronic heart failure (CHF) regarding the USFDA approval of the drug.

The company secured final USFDA approval from the US Food and Drug Administration (USFDA) to market its generic version of Sacubitril/Valsartan tablets.

This medication is a combination therapy that offers a vital treatment option for managing CHF in adult patients.

Sacubitril/Valsartan: A Powerful Duo for Heart Failure

  • Combating Chronic Heart Failure: Sacubitril/Valsartan is a well-established treatment for chronic heart failure. This condition weakens the heart’s ability to pump blood effectively throughout the body.
  • Reducing Hospitalization Risk: Studies have shown that Sacubitril/Valsartan can significantly reduce the risk of hospitalization for CHF complications.
  • Lowering Mortality Rates: This medication has also been demonstrated to decrease the risk of death associated with chronic heart failure.

Zydus Poised to Meet Growing Demand

The USFDA approval allows Zydus Lifesciences to manufacture and distribute their generic Sacubitril/Valsartan tablets within the United States.

This is a major development as this medication represents a growing segment of the CHF treatment market, with in annual sales potential.

Zydus will leverage their established formulation manufacturing facility in Moraiya, Ahmedabad, India, to produce these tablets.

This ensures a reliable and cost-effective supply chain for patients in the United States.

A Win for Patients and the Medical Community

The availability of a generic Sacubitril/Valsartan option from Zydus Lifesciences presents several advantages:

  • Increased Treatment Accessibility: With a generic version available, more patients will likely have access to this life-saving medication due to potentially lower costs compared to brand-name drugs.
  • Enhanced Treatment Options for Physicians: Physicians treating chronic heart failure will now have a broader range of treatment options to consider when creating personalized care plans for their patients.
  • Promoting Innovation: The introduction of generic medications fosters competition within the pharmaceutical industry, which can ultimately lead to lower drug prices and continued research into new and improved heart failure treatments.

The USFDA approval of Zydus Lifesciences’ generic Sacubitril/Valsartan tablets marks a significant step forward in the fight against chronic heart failure.

This medication offers hope for improved patient outcomes and a brighter future for those living with this condition.

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PCI frames new Regulations in accordance with Jan Vishwas Act

Jan Vishwas

The Pharmacy Council of India (PCI) has taken a significant step towards streamlining enforcement procedures under the Pharmacy Act, 1948 in accordance with Jan Vishwas Act.

This move aligns with the recent Jan Vishwas (Amendment of Provisions) Act, 2023, which aims to simplify regulations and ease business operations.

Key Highlights of the Proposed Regulations:

Establishment of a New Chapter:

The PCI proposes adding a dedicated chapter (likely Chapter 12) to its regulations.

This new chapter will outline clear procedures for conducting inquiries, imposing penalties, and handling appeals related to specific violations of the Pharmacy Act.

State Council’s Role in Enforcement:

The proposed regulations empower the President of each State Pharmacy Council to act as the adjudicating officer.

This officer will be responsible for authorizing inspections, conducting inquiries, and imposing penalties for violations like practicing pharmacy without registration or falsely claiming registration status.

Inquiry Process:

A formal inquiry will be initiated upon receiving a complaint against an unregistered individual posing as a registered pharmacist.

The President of the State Council will appoint inspectors to investigate the matter and submit a detailed report within 14 days.

The Registrar or Secretary of the State Council will then review the findings and decide whether to dismiss the complaint or proceed further.

Penalty Imposition:

If the investigation reveals sufficient evidence, a penalty may be imposed in accordance with the Pharmacy Act.

The proposed maximum penalty for a first offense is ₹1 lakh, while subsequent offenses can attract a fine of up to ₹2 lakh.

Appeal Mechanism:

Right to Appeal:

The proposed regulations uphold the right to appeal for individuals contesting the adjudicating officer’s decision.

An appeal can be filed with the President of the PCI (appellate authority) within 45 days of receiving the penalty order.

Appeal Process:

Appeals must be submitted in the form of a petition with supporting documents.

The President of the PCI or a designated official will conduct a preliminary review to ensure the appeal meets all requirements.

If deemed valid, a hearing will be scheduled.

Following the hearing and due consideration, a written decision will be issued within 90 days of filing the appeal.

Background and Rationale:

The Jan Vishwas Act introduced Section 43A into the Pharmacy Act, streamlining the adjudication process for specific offenses.

This new section empowers State Pharmacy Council presidents to handle inquiries and impose penalties, ensuring a more efficient enforcement system.

Additionally, the Act replaces harsh penalties like imprisonment with reasonable fines, promoting a business-friendly environment.

Public Consultation and Implementation:

The PCI is currently seeking feedback from stakeholders on the proposed regulations.

Comments can be submitted until August 10, 2024.

Once finalized, these regulations will provide a clear and well-defined framework for enforcing the Pharmacy Act, fostering transparency and fairness in the process.

Overall Impact:

The proposed regulations by the PCI represent a positive step towards a more efficient and transparent enforcement system for the Pharmacy Act.

This aligns with the government’s broader initiative to simplify regulations and enhance ease of doing business.

The streamlined inquiry, penalty, and appeal procedures will benefit both regulatory bodies and individuals practicing pharmacy.

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USFDA declines to approve this weekly Insulin

Insulin

In a move impacting the diabetes treatment landscape, the US Food and Drug Administration (USFDA) has requested additional information from Novo Nordisk concerning its once-weekly basal insulin icodec.

This news, announced by the Danish drugmaker, delays potential wider availability of the treatment in the United States.

USFDA Seeks Clarification

The USFDA issued a “complete response letter” to Novo Nordisk, outlining its need for further data on two key areas:

  • Manufacturing Process: The regulatory body requires more details regarding the production of icodec to ensure it meets stringent quality and safety standards.
  • Type 1 Diabetes Indication: Concerns were raised about the use of icodec in patients with Type 1 diabetes, specifically regarding the potential for hypoglycemia (low blood sugar) events.

Next Steps

Novo Nordisk acknowledged the USFDA’s requests and stated they would not be able to address them entirely within 2024.

The company remains committed to collaborating with the USFDA to determine the necessary steps for approval and bring icodec to patients in the US.

Background

Icodec, if approved, would represent a significant advancement in diabetes management.

By offering a once-weekly injection compared to the current standard of daily or multiple daily injections, icodec has the potential to improve treatment adherence and quality of life for patients.

However, the USFDA’s decision reflects some of the concerns raised during the application review process.

An external panel previously expressed reservations regarding the use of icodec in Type 1 diabetes due to potential blood sugar fluctuations.

Global Availability of icodec

While the US approval process faces a hurdle, it’s important to note that icodec has received approval under the brand name Awiqli in other regions, including Europe, Canada, Japan, and Australia.

This suggests that Novo Nordisk remains confident in the drug’s efficacy and safety profile.

Looking Ahead

The delay in icodec’s US approval is a setback for both Novo Nordisk and patients seeking a more convenient insulin treatment option.

It also highlights the USFDA’s rigorous approach to ensuring medication safety and efficacy.

While the timeline for US availability remains uncertain, Novo Nordisk’s commitment to working with the USFDA offers hope for a future approval.

In the meantime, patients with diabetes should continue to follow their current treatment plans as directed by their healthcare providers.

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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