Tag: Pharmaceuticals

Granules India faces significant revenue loss following cyber security attack

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Granules India on Thursday warned of a significant loss of revenue and profitability due to a cyber security attack that the pharmaceutical company faced late last month.

Due to significant changes in its IT systems, the IT security incident caused a major disruption in its business operations, the Paracetamol maker said in an exchange filing.

On May 25, Granules India reported the information security incident, adding that impacted IT assets affected have been isolated.

ALSO READ | India sees 18% increase in weekly cyber attacks in Q1 2023: Report

The company said on Thursday that a ransomware group had claimed responsibility for the incident.

The company said it had managed to restore production to near-normal levels at present, however, it flagged backlogs and delays in the clearance of materials for quality system approvals for dispatching the products.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Sun Pharma gets approval from Health Canada for acne drug ABSORICA LD

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Sun Pharmaceutical on Monday, June 26, 2023, announced that its arm Sun Pharma Canada Inc. has received Health Canada approval for ABSORICA LD (isotretinoin capsules). Absorica LD is used to treat severe acne in patients 12 years of age and older.

Sun Pharmaceutical in a release said, “ABSORICA LD is a new formulation of isotretinoin, the first in over a decade, and the only micronized formulation of isotretinoin to treat severe acne in patients 12 years of age and older.”

Severe acne causes breakouts that often extend deep into the skin, including cysts and nodules which disfigure the face. These breakouts tend to be painful, and negatively impact a patient’s quality of life. Even as severe acne clears, acne scars and pigmentation often appear.

The company says, ABSORICA LD is the only micronized formulation, which provides enhanced bioavailability resulting in comparable rate and extent of isotretinoin exposure with or without food. In clinical trials, isotretinoin achieved complete or near-complete suppression of acne within a single course of therapy, and demonstrated complete and prolonged remission of acne.

ABSORICA LD is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne in patients 12 years of age and older, and is taken orally with or without food, taken as whole capsules either as a single dose or in two divided doses, as instructed by a physician. Because of significant adverse reactions associated with its use, ABSORICA LD is reserved for patients with severe nodular acne who are unresponsive to standard therapy, including systemic antibiotics.

Capsules come in 8 mg, 16 mg, 24 mg and 32 mg strengths. Each box comes with 30 capsules as three blister packs of 10 capsules each.

Besides, earlier on June 19, 2023, the arm Sun Pharma Canada received Health Canada’s approval for WINLEVI (clascoterone cream 1%). The company says, WINLEVI is the first and only androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne) in patients 12 years of age and older.

Shares of Sun Pharmaceutical closed 0.66 percent higher at Rs 998/share today, June 26,2 023, on NSE.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Health Minister Mansukh Mandaviya launches National Medical Device Policy 2023

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Minister of Health and Family Welfare Mansukh Mandaviya on Friday launched the National Medical Device Policy 2023 at an annual conference on Indian pharmaceuticals and medical devices in Delhi.

He also launched the Export Promotion Council for Medical Devices and the Scheme for Assistance to Medical Devices Clusters for Common Facilities (AMD-CF) and released six reports on pharmaceuticals and medical devices.

In the coming days, the health ministry will also bring forth a basic chemical and API-related PLI, Mandaviya said. APIs or active pharmaceutical ingredients are the biologically active components of medicinal products that produce the intended effect.

The Cabinet approved the National Medical Device Policy 2023 on April 26, but the policy and its official strategy document were officially released and unveiled by Mandaviya today.

ALSO READ | India’s National Medical Device Policy to bring down import dependence — what more it offers

Bargaining with the quality of medical products will damage India’s growth, competitiveness and reputation, Mandaviya said. He emphasised that he will not tolerate that.

This statement comes days after India made the quality check of cough syrups exported from India mandatory. India-made syrups, in the past year, have been linked to dozens of deaths in Gambia and Uzbekistan.

“I hope the industry will cooperate in the actions taken by the government to maintain the quality,” Mandaviya said.

As India holds the title of “Pharmacy of the World,” our responsibilities have now doubled, Mandaviya added. He emphasised on the importance of innovation in order for the nation to survive the pharma race.

His thoughts were echoed by Kallam Satish Reddy, the Chairman of Dr Reddy’s Laboratories, who said that looking forward, the goals India sets for its pharmaceutical and medical devices industry are critical. While there is opportunity and support from the government and the industry, innovation is required at all levels.

If we are able to discover drugs and market them ourselves, we can push India from being a $42 billion industry to its 2024 goal of being a $65 million industry, Reddy said.

Co-hosted by the Department of Pharmaceuticals and the Federation of Indian Chambers of Commerce and Industry (FICCI), the annual International Conference on India Pharma and India Medical Devices marked its 8th edition today. While day 1 of the two-day event focuses on medical devices, the May 27 sessions will centre around pharmaceuticals.

The conference is aimed at establishing India as a cost-effective, high-quality manufacturing and innovation centre for the pharmaceuticals and medical device industry.

ALSO READ | India makes quality check of cough syrup formulations mandatory before export

The event was attended by eminent dignitaries, senior officials of the Government of India and representatives of the industry and academia.

These include Union Minister of Health and Family Welfare and Chemicals and Fertilizers of India Mansukh Mandaviya, Union Minister of State for Chemicals and Fertilizers and New and Renewable Energy Bhagawanth Khuba, Department of Pharmaceuticals Secretary S Aparna, Joint Secretaries N. Yuvaraj (pharmaceuticals) and Srikar K Reddy (Commerce). Principal Scientific Adviser to the Government of India Ajay Kumar Sood, FICCI Secretary General Shailesh Pathak, Transasia Bio-Medicals Ltd. CEO Aravind Viswanathan and Dr Reddy’s Laboratories Chairman Kallam Satish Reddy also attended day 1 of the conference.

The inaugural event was followed by a CEO roundtable which Mandaviya will attend. The health minister just yesterday conducted bilateral meetings with member countries at the 76th World Health Assembly in Geneva, Switzerland.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

If you’ve bought this thyroid drug from Abbott, check the batch number — the company has started a recall

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Abbott India Limited has issued a voluntary recall of one batch of Thyronorm tablets, a hypothyroidism treatment, due to a labelling error. The pharmaceutical company told CNBC-TV18 that it is working with distributors to facilitate the recall, which applies only to one batch invoiced in Madhya Pradesh and Telangana.

The affected batch, Batch No. AEJ0713, has a manufacturing date of March 2023 and was invoiced only in the states of Madhya Pradesh and Telangana.

The company has confirmed that a small percentage of bottles from this batch have been mislabeled with the dose strength as 25mcg, whereas the bottles actually contain 88mcg tablets.

ALSO READ | Abbott India Q3 net profit at Rs 247 crore, revenue up 8% at 1,326 crore

This labelling error could potentially cause serious health risks to patients who are prescribed the incorrect dose of Thyroxine Sodium.

In a public notice issued by Abbott India Ltd., the company has urged patients who have recently purchased Thyronorm with Batch No. AEJ0713, manufactured in March 2023 and expiring in February 2025, to return the bottle to the chemist they purchased it from or notify Abbott via email or phone.

Abbott India Ltd. has assured the public that this issue is limited to the affected batch and does not extend to any other batch or dosage strength of Thyronorm or any other Abbott products.

ALSO READ | These are four reasons why the street is sulking over the IPCA-Unichem deal

Patients who have been prescribed Thyronorm for the treatment of hypothyroidism are advised to check the batch number and manufacturing date on the label of the bottle to ensure that they have not purchased the affected batch.

Those who have purchased the affected batch are advised to return the bottle to their pharmacist or contact Abbott India Ltd. for further instructions.

In a notice to CNBC-TV18, Abbott India wrote, “We are working with our distributors and other partners to facilitate this recall. This batch has been invoiced only in MP and Telangana. This issue does not affect or extend to any other batch or dosage strength of Thyronorm or other Abbott products.”

ALSO READ | Soon, medicines to come with QR code to check sale of fake drugs

Back in October 2022, Abbott’s Thyronorm was listed as being “not of standard quality” by the Telangana government, Business Standard reported.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

WHO says contaminated cough syrups made in Punjab found in Western Pacific nations, company dismisses claim

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The World Health Organization (WHO) on Tuesday said that a contaminated cough syrup made by an Indian company has been found in the Marshall Islands and Micronesia. As per the WHO Medical Product Alert, reference was made to a batch of substandard (contaminated) Guaifenesin Syrup TG Syrup, which is an expectorant used to relieve chest congestion and the symptoms of cough. The company, QP Pharmachem, has denied this claim.

The ‘substandard’ syrup was reported to WHO on April 6. This comes after reports of a spate of child deaths linked to similar contaminated cough syrups emerged in Gambia and Uzbekistan, respectively.

According to WHO, samples from the Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia.

The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. The stated manufacturer of the affected product is QP Pharmachem Ltd from Punjab and the stated marketer of the product is Trillium Pharma in Haryana.

ALSO READ | Made in India cough syrups linked to child deaths in Gambia: US CDC

In its alert, WHO said, “The product referenced may have marketing authorisations in other countries in the Western Pacific region. It may have also been distributed, through informal markets, to other countries or regions. The substandard product referenced in this Alert is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”

Adding to the alert, WHO has recommended refraining from the usage of this syrup.

“WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory authorities/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country. Healthcare professionals should report any suspicious cases of adverse events linked to the use of these contaminated medicines to the National Regulatory Authorities/ National Pharmacovigilance Centre,” WHO added.

ALSO READ | WHO investigating links between cough syrup deaths, considers advice for parents

However, QP Pharmachem said WHO tested expired samples of the cough syrup and was dismissive of the results.

“Our company had dispatched a total of 18,336 bottles of the cough syrup in November 2020 and the shipment was only meant to be exported in Cambodia as per the order. We have no idea why WHO sent the samples to Australia for testing without any prior communication and now we are being framed in this allegation for contamination,” Sudhir Pathak, MD, QP Pharmachem exclusively told CNBC-TV18.

“WHO has taken samples of the consignment which was supposed to reach Cambodia and had them tested at the Therapeutic Goods Administration (TGA) of Australia. All this happened without me and officials of our company being informed. Firstly, our medical product does not even match the standards and norms laid down by Australian FDA. The consignment was supposed to be delivered to Telpha Care in Cambodia but was deliberately landed in Micronesia and Marshall Islands,” he added.

According to Pathak, a week ago, he received a communication from the WHO regarding this. Later, the Punjab state FDA and Drug Controller General of India (DCGI) officials visited his manufacturing unit and conducted inspection and also took samples for further examination.

“We have to wait for at least 10-15 days for the reports to come in but we are confident of coming out clean in this,” Pathak added.

ALSO READ | Cough syrup deaths: Health Minister, regulators, policy officials to brainstorm on fighting trust deficit

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Shilpa Medicare secures final US FDA nod for psoriatic arthritis drug

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Shares of Shilpa Medicare gained over 10 percent on Tuesday,  after the pharmaceutical company said on Monday that it received the United States Food and Drug Administration’s (USFDA) final approval for its Abbreviated New Drug Application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg. Apremilast Tablets are used for the treatment of adult patients with active psoriatic arthritis.

The product is executed from a contract manufacturing site, the company said in a statement.

Shilpa Medicare revealed that Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.

Also Read: These two pharma companies provide best medium to long term earnings growth visibility, according to Jefferies

The US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately $3.55 billion, according to IQVIA MAT Q4 2022 data.

Last month, the Bengaluru-headquartered company received 2 observations by US FDA for its Unit 7 at Hyderabad. In February, the company’s Bengaluru facility Unit 6 registered with Ministry of Health, United Arab Emirates, which enabled the company to register products in UAE for commercialisation.

Shilpa Medicare revealed its Q3 earnings in February. The company reported a net loss of Rs 6.6 crore against a profit of Rs 9.6 crore in the same quarter last year. The company’s Earnings before interest, taxes, depreciation and amortization (EBITDA) also plummeted over 30 percent to Rs 31.3 crore against Rs 45.1 crore in the same quarter last year.

The shares of Shilpa Medicare were trading 10.5 percent higher on the BSE at Rs 257.7 apiece around 11am.

Also Read: Future Female Forward | Here’s how Cipla is creating a women-friendly workplace

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

M&A Outlook 2023 — here’s why pharma to be a promising sector for further investments this year

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The Indian pharmaceutical, healthcare and biotech sector has been attracting increasing levels of investor interests. The sector has witnessed a remarkable spike in deal value in 2022, by touching $6.14 billion as against $3.69 billion during 2021.

Interestingly, it is the large domestic companies doubling down on the Indian market that has backed these mergers and acquisition (M&A) activities. Some of the notable deals include Torrent Pharma’s buyout of the dermatology firm Curatio Healthcare and Mankind Pharma’s acquisition of Panacea’s domestic formulation brands. Private equity has also claimed a significant chunk of deal activity in 2022 including notable deals such as Abu Dhabi Investment Authority’s investment of $250 million (approx.) into Intas Pharmaceuticals.

Foreign investment into the pharmaceutical sector during the first six months of 2022 was $699 million as against $559 million recorded during the same period of 2021. Further, the Department of Pharmaceuticals approved 21 FDI proposals worth Rs 46.8 billion for brownfield pharmaceutical projects during the first nine months of 2022.

 Key Regulatory and Policy Initiatives

The sector has witnessed important regulatory and policy initiatives in 2022. Of particular importance is the release of the New Drugs, Medical Devices and Cosmetics Bill (“DMC Bill”) in July 2022, which seeks to amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics into a single legislation, with an intention to update the pre-independence legislation of the Drugs and Cosmetics Act, 1940, and to meet the evolving needs, including, a proposal to regulate the ever growing space of e-pharmacies for the first time, new definition of ‘drugs’ and ‘medical devices’ placing them outside the purview of ‘drugs’, constitution of the Drugs, Medical Devices and Cosmetics Consultative Committee to ensure uniformity in administration across the county and new provisions around clinical trial management. 

Foreign Exchange Regulations

With the notification of the new overseas investment (OI) regime in August 2022, the Ministry of Finance and Reserve Bank of India have significantly streamlined the regulations governing the outflow of foreign exchange and investments from India. The new regime may enable Indian entities with opportunities to acquire strategic assets overseas at an attractive valuation in an otherwise declining global economy due to inflation and war. The OI regime also permits more structuring flexibility for Indian entities to undertake an acquisition through their overseas subsidiary, for a bona fide business purpose. On the other hand, India’s Foreign Direct Investment (FDI) Policy for investment in the pharma and medical devices sector remains unchanged with FDI up to 74 percent under the automatic route into brownfield pharmaceutical and up to 100 percent under the automatic route permitted for greenfield pharmaceutical investments. Investments above 74 percent into brownfield pharmaceutical continue to require government approval. Further, FDI from an entity of a country sharing land border with India, or where the beneficial owner of an investment into India is situated in or is a citizen of any such country also continues to require prior government approval. 

Policy Initiatives 

The Indian government has also undertaken several policy initiatives to boost the sector. Some notable initiatives include:

• The new National List of Essential Medicines was released in September 2022 after a gap of seven years, with the intent to promote the rational use of medicines based on cost, safety and efficacy. 

• The Parliamentary Standing Committee on Chemicals and Fertilisers, in a report submitted in the Lok Sabha in August, 2022, has recommended to the Central Government to exempt the basic customs duty as well as Goods and Services Tax on medicines and medical devices used to combat Covid-19. The report seeks such exemption until the pandemic is over.

• In relation to medical devices, the Parliamentary Standing Committee on Health and Family Welfare, in a report submitted in the Rajya Sabha on ‘Medical Devices: Regulation and Control’, considered latest developments in the regulatory structure of medical device industry and provided measures to be undertaken in order to ameliorate the manufacturing framework to promote the production of medical devices in the country. Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has also released a draft of the ‘National Medical Devices Policy 2022’ listing out various measures for regulatory streamlining and technology upgradation. Further, in order to promote export of medical devices from India, the Ministry of Commerce and Industry has decided to set up an Export Promotion Council for Medical Devices.

• In March 2022, the Indian government introduced the ‘Strengthening of Pharmaceutical Industry Scheme’, wherein a total financial outlay of around INR 5 billion was announced for the period FY 2021-22 to FY 2025-26 to strengthen the existing infrastructure facilities in the sector by providing financial assistance to SMEs, MSMEs and pharma clusters.

Way Forward: 2023 Outlook

The pharmaceutical and healthcare sector is expected to log a growth of 8-10% in the upcoming fiscal year. It is also anticipated that businesses will continue to reassess the risk of their dependencies on global supply chains and look for organic and inorganic opportunities in India to reduce their supply chain dependency on a single jurisdiction, given the COVID-19 pandemic and the more recent Russia-Ukraine war which has had a significant impact on the operations of the pharmaceutical companies internationally. Accordingly, 2023 may see more diverse deals across value chains, from manufacturing, R&D to product marketing and distribution. Private equity players are also expected to continue looking for attractive opportunities in the sector and also look for exit opportunities through secondary sale.

Companies with innovative capabilities, such as telehealth or innovation in medical devices space, are also attracting significant investor attention. It is expected that 2023 will see more capability-driven deals providing access to newer technologies as large pharma companies are looking to divest non-core assets and optimise their portfolio. However, volatile public markets and rising interest rates may put additional pressure on the ability of corporations and investors to undertake M&A.

FDI in the sector may also increase as several MNCs are looking at opportunities in emerging markets to provide growth. As a result, this will further boost M&A in the Indian pharmaceutical sector. The policy initiatives mentioned above are also intended to tackle issues such as lack of adequate infrastructure and logistics, concentrated supply chains and high cost of finance and lack of substantial tax or financial incentives available to set up domestic manufacturing. 

India is however not immune to the global developments around the sector. The US government’s recent measures as part of its budget announcements to reduce the prices of drugs, is likely to have an impact on the revenue of Indian entities exporting to or dependent on the US market. Similarly, India also has strong competition from other emerging economies in the South-East Asian and Arab region to gain larger market share of API manufacturing where certain Chinese companies are also looking to form alliances. While these geo-political developments may impact the growth of Indian companies, it also creates an opportunity for the Indian companies to gain larger market share in the US as well as form manufacturing alliances in the South-East Asian and Arab region. 

Conclusion

As India enters the ‘Amrit Kaal’, it is expected to remain one of the faster growing major economies in the world due to robust domestic demand. Deal activity is anticipated to increase with the pharmaceutical and healthcare sector continuing to be a promising sector for further investments in 2023. The role of professional advisors in this regulated sector in India will also play a significant part as Investors navigate through the legal, regulatory, financial and operational complexities involved in undertaking a M&A transaction in this sector.

—The authors, Ravi Shah, is Partner, and Avani Dalal, is Senior Associate, at   law firm Cyril Amarchand Mangaldas. The views expressed are personal.  

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Biden’s Budget: Here’s how the new proposals likely to affect Indian drugmakers

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

President Joe Biden on Thursday announced a $6.9 trillion budget which includes several measures aimed at reducing the cost of prescription drugs and healthcare. The budget builds upon the Inflation Reduction Act (IRA) to continue lowering the cost of prescription drugs.

The announcements are of particular interest to India whose top five pharma export destinations are the United States, United Kingdom, South Africa, Russia and Nigeria.

India’s pharma exports amounted to Rs 1,83,422 in 2021-22, a 103 percent increase since 2013-14. The nation ranks third worldwide for production in terms of volume and 14th by value and shares a 5.92 percent share of drugs and pharmaceuticals in global trade.

One of the key proposals in the US’ latest Budget is to expand the ability of Medicare, the government national health insurance program in the US, to negotiate drug prices, which will increase the number of drugs that Medicare can select for negotiation and bring more drugs into the negotiation process sooner. The reforms are expected to save the federal government $160 billion over 10 years, while also saving billions of dollars for seniors.

The budget also includes proposals to limit Medicare Part D cost-sharing for high-value generic drugs for certain chronic conditions to no more than $2. In addition, it proposes to strengthen the Medicaid Drug Rebate Program by giving the Department of Health and Human Services the authority to negotiate additional, supplemental Medicaid drug rebates on behalf of states in order to increase purchasing power.

“We pay more for prescription drugs in America than any other advanced nation on Earth. Let me say that again. In the United States of America, for whatever prescription drug you’re buying, you’re paying more than any other nation on Earth that’s an advanced nation,” Biden highlighted in his speech.

ALSO READ | Joe Biden unveils $6.9 trillion budget, raises taxes on rich

Another proposal is to require drug companies to pay rebates for commercial drug sales, as well as sales to Medicare, when their price increases for certain drugs exceed inflation. This measure is expected to save the federal government $40 billion and reduce health insurance premiums for people with private health insurance coverage.

The budget also aims to lower Medicaid spending by addressing excessive payments to Medicaid Managed Care Organizations. The proposal would require insurance companies that are charging Medicaid far more than they actually spend on patient care to pay back some of the excess. The budget estimates this would lower Medicaid costs by over $20 billion.

On drug prices, Biden highlighted the example of Eli Lilly, which announced a cap on the cost of insulin at $35 a month, claiming that it would save lives.

“Now, how are the rest of these folks going to charge more than that when you can go to Eli Lilly and buy them for 35 bucks a month? So, folks, it’s going to save a lot of lives,” Biden said.

ALSO READ | Drug Diplomacy—Here’s why India needs a stricter pharma regulation

Finally, the budget proposes to lower Medicaid costs by improving access to HIV prevention and care programs, including access to pre-exposure prophylaxis (PrEP), among Medicaid beneficiaries. The budget also proposes to create a subscription model for drugs to treat Hepatitis C, which is expected to reduce Medicaid spending by hundreds of millions of dollars each year by 2032.

Most of the proposals in the Biden Budget thus could impact the overall revenue of drug exporters from India, especially the top ones, including Sun Pharma,  Lupin, Aurobindo, Glenmark, Dr Reddy’s among others, as a large chunk of revenue and profit of these companies are earned from the US, which is the world’s largest market for pharmaceuticals in terms of value.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Cough syrup deaths: Health Minister, regulators, policy officials to brainstorm on fighting trust deficit

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Following the deaths of over 70 children linked to “substandard” cough syrups, the Government of India has decided to organise a two-day meeting with pharmacy experts and regulatory officials. The Union Ministry of Health and Family Welfare in collaboration with the Department of Pharmaceuticals will host this two-day ’Chintan Shivir’ in Hyderabad from February 26.

The event aims to brainstorm and find ways to establish trust in Indian drugs, cosmetics, and medical devices in both domestic and export markets, especially after the recent incident. Additionally, it will focus on enhancing regulations to ensure that these products meet higher quality standards in the future.

According to a News18 report, industry officials claim that the event will be headed by Union Health Minister Mansukh Mandaviya and will be the first meeting of its scale.

Among other attendees will be representatives from NITI Aayog, the Ministry of AYUSH, the National Health Authority and the National Pharmaceutical Pricing Authority, News18 said.

The news of the Chintan Shivir on ’Drugs: Quality Regulations and Enforcement’ comes amid concerns over the quality of certain Indian drugs, such as instances of Global Pharma Healthcare recalling entire lots of eye drops linked to vision loss in the US and Indian-made cough syrups being linked to children’s deaths in Gambia and Uzbekistan.

The World Health Organisation on January 11 had also issued a warning against the use of “two substandard (contaminated) products” manufactured by Marion Biotech Pvt. Ltd. in Uttar Pradesh.

ALSO READ | WHO warning on Maiden Pharma cough syrups — How can low-quality ingredient become a killer

“Discussions will focus on the present enforcement mechanism in place to address spurious, adulterated and substandard drugs, and the necessity for greater coordination between the states and the Centre in this regard and the issues and challenges in enforcement,” an official said.

The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority responsible for the approval of new drugs, conducting clinical trials, ensuring the quality of imported drugs, and providing expert advice to State Drug Control Organizations.

The CDSCO operates under the Drugs and Cosmetics Act, and its role is to promote uniformity in the enforcement of the act.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Economic Survey 2023 | Domestic pharmaceutical market to reach $130 billion by 2030

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The Economic Survey 2023 projects that India’s domestic pharmaceutical market will reach $130 billion by 2030, sustained by the country’s continued growth in the industry despite the COVID-19 pandemic.

Finance Minister Nirmala Sitharaman tabled the survey during a joint session of the Parliament of India on Tuesday.

India ranks 3rd in global production of pharma products by volume and 14th by value, the survey reported. It is also the largest global provider of generic medicines contributing 20 percent of global supply and is the leading vaccine manufacturer with a 60 percent market share.

“The Indian pharmaceutical industry plays a prominent role in the global pharmaceutical industry,” the survey said.

ALSO READ: Economic Survey 2023: Top 10 key highlights

The domestic pharmaceutical market was estimated at $41 billion in 2021 and expected to reach $65 billion by 2024. It is further expected to reach $130 billion by 2030.

India’s pharmaceutical exports achieved a 24 percent growth in FY21, driven by COVID-19 demand for critical drugs and other supplies in 150 countries, and sustained growth in FY22 despite global disruptions.

“The performance of pharma exports in FY22 has been robust, sustaining growth despite the global trade disruptions and drop in demand for COVID-19-related treatments. Carrying forward this growth momentum, drug and pharmaceutical exports during April-October 2022 was 22 percent higher than the corresponding pre-pandemic period of FY20,” it said.

Foreign investment in the pharma sector has also increased, crossing the $20 billion mark in September 2022.

FDI inflows reached $699 million by September 2022 after increasing four times over since 2017. This bump was supported by investor-friendly policies and positive outlook for the industry, the pre-Budget document said.

ALSO READ: Economic Survey 2023 | Electronics industry records 4x growth in last three years

The government regulates drug prices through National Pharmaceuticals Pricing Policy and provides affordable generic medicines through Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP).

The Department of Pharmaceuticals and the National Pharmaceuticals Pricing Authority has fixed ceiling prices of 119 formulations under the National List of Essential Medicines (NLEM) until December 31, 2022. In addition, retail prices for 2,196 formulations have been fixed under the Drugs (Prices Control) Order, 2013, the survey added.

“Until December 31, 2022, ceiling prices for 890 formulations of 358 drugs/medicines across various therapeutic categories under the NLEM 2015 have been fixed by the National Pharmaceuticals Pricing Authority,” the survey said.

By the end of 2022, over 9,000 Pradhan Mantri Bhartiya Janaushadhi Kendras were opened under the PMBJP across India offering 1759 medicines and 280 surgical devices.

With agency inputs.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow