Stop Abuse Of Patent Monopolies In Rare Diseases, Say Patient Representatives And Treatment Activists

New Delhi: Roche, a Swiss multinational healthcare company, is seeking a permanent injunction against Natco Pharma to prevent the introduction of a generic version of Risdiplam, a Spinal Muscular Atrophy (SMA) drug, citing patent infringement.

Health groups on Tuesday (November 5, 2024) argued that Roche’s legal action to block generic supply jeopardises public interest by limiting access to affordable medication. Roche’s patent for Risdiplam is effective until 2035, allowing them to charge approximately ₹6 lakh per bottle, while production costs suggest the drug could be made available for as low as ₹3,024 annually.

Roche’s action in Delhi High Court seeking an injunction against Natco Pharma to prevent the introduction of a generic version of the drug called risdiplam will jeopardise public interest by compelling patients to rely on the Roche product that costs ₹6 lakh a month, they said.

Risdiplam is the first oral medication against SMA, a congenital neuromuscular disorder marked by progressive muscle weakness, loss of movement control, and muscle wasting and classified as a “rare disease”. Roche has a patent on risdiplam in India until 2035.

SMA affects roughly one in 7,700 live births in India.

The Union health ministry had decided in May 2022 to provide ₹50 lakh per patient for the treatment of rare diseases, but patients’ rights advocates argue that inexpensive generic versions will be critical for sustainable government support for treatment.

“Roche’s action against Natco comes at a time when multiple patients with SMA and other rare diseases have approached courts seeking sustainable treatment options,” said Leena Menghaney, a public health lawyer and member of a network campaigning for access to inexpensive medicines.

The network called Working Group on Access to Medicines and Treatments has cited an analysis by Melissa Barbar, a public health researcher at Yale University in the US, which estimated that generic risdiplam could be priced at ₹3,024 per patient per year.

“This includes the cost of production with a 20 per cent markup and 25 per cent tax,” the Working Group said in a statement released on Tuesday. “Risdiplam is less complex to manufacture than other treatments for SMA. Production in small volumes is feasible and cost-effective.”

Provisions in Indian laws on patents allow the Centre to enforce a so-called compulsory licence to enable generic versions of patented molecules if there is a large unmet need, experts say.

And generic drug makers could also challenge already-granted patents seeking invalidation, said Chetali Rao, a member of the Third World Network, a think tank that engages in healthcare and other issues that impact developing countries.

“There is a huge unmet need in the case of risdiplam — the vast majority of patients in India will have no access to a medicine that costs ₹72 lakh a year and that needs to be taken throughout life,” said Rao.

A Roche spokesperson, responding to a query from this newspaper seeking a response to the concerns by patients’ rights groups, said Roche “is committed to deliver healthcare innovations that significantly improve patients’ lives in the country while ensuring that as many patients as possible have access to our products”.

“…We are also committed to protect our innovations within the scope of applicable laws in the countries we operate and believe that laws provide sufficient safeguards for protection of innovation,” the spokesperson said.

Roche, under a patient-support programme announced in 2021, would during the first two years of treatment provide three bottles free for every two bottles bought by the patient. From the third year onwards, the company would provide two bottles free for every one bottle bought by the patient. But, Rao said, the patient-support programme is likely to make little difference to most patients.

Source : The Telegraph India

Nursing Degree Holder Running Clinic, Sealed

Banswara: The team of the District Medical and Health Department comprising CMHO Dr. HL Tabiar, Deputy CMHO Dr. Rahul Dindor and District Tuberculosis Officer Dr. PK Verma took action at two places on Monday.

A person with a BSc Nursing degree was found running a clinic in Motagaon. A female patient was also found admitted here. The clinic was not registered.

There was no license from the Pollution Control Board and no arrangements for bio waste disposal. According to the rules, a person with a BSc Nursing degree can run a clinic after registration but he has to hire a doctor to treat patients. Medicines can be given only on the prescription of a doctor. Other licenses also have to be taken. The CMHO has sealed the clinic.

Instructions were given to get registered and to provide treatment only on doctor’s prescription. Based on a complaint received at the CMHO office, the team raided a house in Sundni. Only spectacles making material was found in the shop outside the house. The CMHO said that a complaint was received about an illegal hospital running in a shop outside the house of a person named Ajit Garg in Sundni village.

There was a machine for eye examination and material for making glasses was kept here. A person named Ajit Garg was not found. The complainant has made a false complaint. No allopathic medicines were found here. While visiting Motagaon, a 108 ambulance was stopped. The driver said that he had come after dropping a patient suffering from stomach ache but there was no other personnel in the ambulance except the driver. On this, the CMHO has directed the District Coordinator to submit a detailed report.

Source : Dainik Bhaskar

Complicated Registration Process On NMR Portal Causing Headache To Doctors

NEW DELHI: Thousands of MBBS doctors are facing an uphill task to register themselves with the National Medical Register (NMR) portal, launched with much fanfare by Union Health Minister J P Nadda in August.

Now, the doctors are asked not only to upload Aadhar but also to submit an affidavit if their names or state medical council names do not match the current data.

This is especially so in the case of Kerala, where the state medical council name has changed, resulting in doctors running pillars to post to register themselves with the NMR, a comprehensive and dynamic database for allopathic registered doctors in India.

The Indian Medical Association (IMA) National President, Dr K V Asokan, told this paper that doctor’s registration has become very complicated and they will take this up with the National Medical Commission (NMC).

“We will certainly take it up. It is a technical problem and must be rectified. It can be easily resolved. The NMC has to simplify the procedure and change the format. They have to delink the registration with the Aadhar. This will make it easy for the practising doctors,” Asokan said.

He also said they had a discussion with NMC Chairman Dr. B.N. Gangadhar about the NMR.

“This single registration process will help doctors practice in one or more states. They don’t have to get a license to practice in multiple states. Earlier, it was difficult for doctors. They had to obtain a no-objection certificate from their medical council before operating in another state. Doctors were facing a lot of harassment and hardship.”

“The new model helps doctors as it doesn’t affect their seniority and mitigates their suffering. However, the NMC must simplify the procedure for doctors to benefit.”

The NMR is mandated under Section 31 of the NMC Act, 2019, which states that the Ethics and Medical Registration Board (EMRB) of NMC shall maintain a national register in electronic form containing the name, address, and all recognised qualifications possessed by a licensed medical practitioner.

Dr Asokan said doctors in Kerala are finding it difficult to register themselves in NMR as the name of the state medical council has changed.

The Kerala State Medical Council (KSMC) was earlier known as the Travancore Cochin Medical Council (TCMC). The name change of the State Medical Council (SMC) was the beginning of the problem for Kerala doctors, who have now been asked to file an affidavit to confirm the name change.

And that’s not all. The NMC’s EMRB also wants the doctors to attach their Aadhar. As Aadhar has become mandatory, thousands of doctors in Kerala are finding themselves in a tough spot as their names differ in their degrees, state medical councils and Aadhar.

According to Dr K V Babu, a vast majority of doctors, approximately 70%, registered with the SMC belong to pre-Aadhar days. Thus, their names differ in degree, Aadhar, or even in the SMC.

“They now have to file an affidavit. The registration process will be a non-starter if the NMC insists on an affidavit. I hope the NMC will make registration as simple as during the Medical Council of India (MCI) days. The MBBS degree and SMC registration certificates are sufficient for registration.”

Citing an example, Babu said his name on the certificate was ‘Babu KV’, and in the Aadhar, his name is ‘Babu Kankokkaran VadakkeVeetil’. “I am not alone; lakhs of doctors like me face the same problem. But the NMC insists that most of the 10 lakh Registered Medical Practitioners (RMPs) should upload an affidavit!”

During the term of the erstwhile MCI, an RMP’s name registered with the SMC was automatically enrolled in the Register. Now, Babu added that the EMRB has asked the RMPs, whose names are already in the Register, to re-register again.

“A simple procedure has been made so complicated. Unless EMRB makes it simple, it will be a total disaster. Hope better sense prevails on the part of the NMC,” he added.

He suggested that the NMC should automatically enroll the RMPs as the MCI did once the SMC verifies the registration number and degree certificates. “There is no need to submit an affidavit.”

Source : The India Express

WHO Approves Zydus Lifesciences’ Typhoid Vaccine For UN Procurement

New Delhi: Indian multinational pharmaceutical company Zydus Lifesciences Ltd on Wednesday announced that its Typhoid Vi conjugate vaccine, ZyVac TCV, has received in-principle approval from the World Health Organization (WHO), paving the way for the vaccine to be eligible for purchase by United Nations (UN) procurement agencies.

With this, the vaccine would be distributed globally in regions most affected by typhoid fever, the pharma said in an exchange filing.

ZyVac TCV is developed and manufactured at the Zydus Biotech Park in Ahmedabad. The vaccine is designed to offer active immunisation against infections caused by Salmonella typhi, a bacterium responsible for typhoid fever. The vaccine will be available for use by a broad age group, from individuals aged between 6 months and 65 years.

With WHO’s prequalification, ZyVac TCV can now be included in the UN’s procurement programme. This is significant as UN agencies procure over 150 million doses of typhoid conjugate vaccines annually to address the prevalence of typhoid in regions such as India, Africa, and Southeast Asia. The vaccine’s eligibility for such large-scale distribution is expected to make a substantial impact in combating typhoid fever, especially in high-risk areas.

Earlier this month, the pharma also received tentative approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide tablets, a generic drug used in the treatment of prostate cancer.

Source : Business Standard

Fake Ashoka Bark Being Used In Ayurvedic Medicines

Ghaziabad : Scientists of the Pharmacopoeia Commission for Indian Medicine & Homoeopathy examined Ashoka bark available in the market. Out of these, more than 15 percent were found to be fake.

Apart from making Ayurvedic medicines, people also use these plants for Ayurvedic treatment at home. In this, Ashoka bark was found to be fake. It is used in many diseases including stomach related diseases, skin diseases, piles, bone related diseases, leucorrhoea.

The Commission’s Chief Scientist Dr. Jayanti A. said that many plants available in the market were brought to the Commission’s laboratory for examination. During the investigation, Ashoka bark available in the market was found to be fake.

She said that Ashoka bark is used by big companies for the manufacture of Ayurvedic medicines. Many times complaints were made by regional officials about this. After this, the Commission’s team examined the Ashoka bark used in markets and companies. Medicines of many big companies have also been examined, in whose samples the use of fake bark has been detected. In this regard, the government as well as the Bureau of Standards have been informed. So that fake plants and medicines can be recovered in time.

Drug inspectors are being trained in the Pharmacopoeia Commission for Indian Medicine & Homoeopathy on how to identify fake medicines and medicinal plants available in the market. So that people’s health is not compromised. During the five-day training programme, apart from identifying plants, they are also given information about their use and application.

Ashoka flowers also cure diseases. The red flowers of Ashoka tree are also a storehouse of medicinal properties. Ashoka tree flowers are a boon for curing skin diseases. It is effective in treating female infertility, uterine disorder, dysentery and various skin diseases. Applying some henna leaves and coconut oil mixed with Ashoka tree flowers provides relief from skin diseases.

Source : Amar Ujala

Medical Store Opening Made Easy In UP

Lucknow: While granting a license to open a pharmaceutical company and sell medicines, entrepreneurs will no longer be subjected to rules like size of the firm, investment, domestic or foreign investor and business risk like other businesses.

Due to its inclusion in Invest UP’s Business Reform Action Plan (BRAP)-2024, entrepreneurs are facing difficulties in getting licenses. In such a situation, the Food Safety and Drug Administration Department has written a letter demanding exemption from this.

While granting license for setting up a pharmaceutical company or for sale of medicines under the Drug and Cosmetic Act, only the storage capacity as per standards, facility to keep medicines at low temperature and registration of pharmacist are considered.

According to BRAP-2024 of Invest UP, the Food Safety and Drug Administration Department has already made arrangements for granting and monitoring licenses through an online portal. There is also a system to deposit fees online for the license and to see with which officer the file is pending or everything online.

In such a situation, Principal Secretary, Food Safety and Drug Administration P. Guruprasad sent a letter to the Chief Executive Officer of Invest UP demanding exemption from rules like size of firm etc. under BRAP, because there is no provision for this in the Drug and Cosmetic Act, hence it cannot be implemented. At present, after getting the exemption, the drug entrepreneurs will get a lot of relief.

Source : Aaj Ki News

FDA Action Against Three Drug Firms For Violations

PUNE: The Food and Drug Administration (FDA), Pune division, has acted against three drug stores for violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

The action was taken between April and October 2024 by the FDA, Pune division said the officials in the statement.

According to officials as per the DMR Act, advertisements for drugs for 54 diseases and disorders that fall under the schedule are prohibited. The schedule explicitly prohibits companies from promoting cures or making claims related to diseases and disorders. These firms were found selling drugs claiming to cure diabetes, arthritis and kidney ailments.

According to FDA officials, the Ayurvedic medicine worth Rs 36,500 has been seized under Section 3 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 from New Maruti Ayurved, Chinchwad, for making an objectionable claim on the label of Amruth Noni D Plus regarding the treatment of diabetes. Besides, Ayurvedic medicine Orthojoint Oil worth Rs 5,027 was seized from Amit Medico, Sadashiv Peth, for making an objectionable claim about the cure of arthritis on the label, they said.

Furthermore, 16 sachets of Ayurvedic medicine worth ₹5,000 were seized from Mahalaxmi Ayurvedic, Pune, for making an objectionable claim about the cure of kidney stones on the label.

Girish Hukare, joint commissioner, FDA(Drug), Pune division, said, in one case of diabetic medicines we have filed a case and investigations in the other two incidents are ongoing.

“The DMR Act 1954 is implemented through the FDA to prevent people from self-medicating for various diseases. Medicines taken without consulting a doctor for serious illnesses can have harmful effects,” he said.

Hukare, further, said, the FDA regularly checks the labelling of medicines available in the market. If misleading claims are found, action is taken against those people.

“Advertisements on television and newspapers are also checked, and if objectionable advertisements are found, the concerned manufacturer is given a notice to stop the advertisement, and further action is initiated by the respective drug authorities,” added Hukare.

Source : Hindustan Times

DCGI Wants Qualified Medical Device Testing Officers

New Delhi: The Drugs Controller General of India (DCGI) is planning to list the qualification criteria for medical device testing officers.

At present, no qualification is needed, with mostly drugs inspectors deputed to do the job.

This follows increasing complaints by the medical device industry – a market that is estimated to be around $11 billion, and expected to grow to $50 billion by 2030.

The matter was discussed in the Drugs Technical Advisory Board (DTAB) last month, which agreed to amend the Drugs Rules.

At present, the Central or state government, by notification, appoints any person it thinks fit to be Medical Devices Testing Officer who picks samples, tests and evaluates such medical devices.

The medical devices testing officer has the power to propose restricting or allowing the import, manufacture or sale of medical devices – “in public interest”.

“The samples of medical devices cannot be picked up the way drugs are picked up. Devices like MRI or CT Scan machines have to be verified on the site itself for safety features. Therefore, it is very important to depute highly skilled technical officers for the purpose,” said an official aware of the matter.

“There’s an acute shortage of competent medical devices officers at Central Drugs Standard Control Organisation (CDSCO) and State Licensing Authorities from an engineering and science background to adequately regulate medical devices that have recently come under regulations,” Rajiv Nath, forum coordinator, AiMeD (Association of Indian Medical Devices Industry).

Due to these shortages pharmacists and drug inspectors have been redesignated as Medical Devices Officers and in many cases these are not experts at the diverse range of engineered medical devices they are supposed to regulate,” he said.

“This becomes a huge challenge to manufacturers as they struggle to communicate with these regulators who see products like defibrillators and ventilators from the eye of medicine. It’s like an Air Force officer telling a naval officer what’s expected by the Air Force. The government needs to address this staffing and competence urgently if we are aiming India to be the leading manufacturing hub for medical devices globally as stated in the National Medical Devices Policy 2023.”

The government has approached various institutions for designating medical device testing laboratories so that medical devices and in-vitro diagnostic devices available in the market can be tested for safety and performance.

In India, medical devices are a category of almost 5,000 products. Different categories of medical devices may require different kinds of testing infrastructure.

Source : Livemint

Mumbai Police Arrest Prime Accused In Rs 81 Lakh Fraud At Pune’s BJ Medical College

Mumbai: Borivali police have arrested the prime accused, Anil Ramchandra Tambat, in a case involving a scam worth approximately Rs 81 lakh related to MD course admissions at Pune’s BJ Medical College. The accused, along with co-conspirators Sandeep Waghmare, Abhijeet Patil, and Bhushan Patil, has been charged with duping a medical professional. The victim was also threatened with his son’s kidnapping and murder if he reported the fraud or demanded his money back.

Mangesh Anant Rane, a resident of Kandivali, runs a medical and surgical supply business. His son, Aditya, completed his MBBS in 2019, scoring 199 marks. Despite his efforts, Aditya could not secure admission to an MD course. About two years ago, Mangesh met Sandeep Waghmare from Nanded. During their acquaintance, Rane shared details about his son’s aspirations. Waghmare then promised to secure Aditya an MD seat through the NRI quota at a reputed college in Aurangabad. Waghmare introduced him to Abhijeet Patil, and they took Mangesh to Aurangabad, where they met Anil Tambat. Together, they assured Mangesh that his son would get a seat through the government quota.

On their suggestion, Aditya reapplied for the NEET exam. Three days later, Mangesh received an email claiming Aditya had secured a seat at BJ Medical College, Pune.

Believing the email was from the official college website, Mangesh followed the next steps and submitted all necessary documents, including Aditya’s certificates. He then paid Rs 94 lakh to Anil Tambat, Rs 8.5 lakh to Abhijeet Patil, Rs 23 lakh to Sandeep Waghmare, and Rs 11 lakh to Bhushan Patil, totalling Rs 1.36 crore. Soon after, they sent Aditya’s admission documents, along with a college ID card, claiming he had been admitted.

However, Mangesh later discovered that the documents and ID card were fake. He also found out that the group had previously defrauded another acquaintance, Vishwanath Balunj, by falsely promising admission for his son.

When Mangesh confronted the group and demanded his money back, they returned Rs 55 lakh but withheld Rs 81 lakh. Instead, they threatened to kidnap and kill his son if he approached the police.

Realizing the extent of the fraud, Mangesh lodged a complaint with the Borivali police. The police registered a case under multiple sections of the IPC against Anil Tambat, Sandeep Waghmare, Abhijeet Patil, and Bhushan Patil. Following a 10-month-long investigation, the police finally arrested Anil Tambat in Aurangabad. He is currently in police custody for further interrogation. The police have also identified the three co-accused and launched a special operation to arrest them.

This case highlights the growing menace of admission scams and the lengths to which fraudsters will go to dupe unsuspecting families.

Source : Lokmat Times

Govt Waives Testing Of Cough Syrups For Export To Key Markets

New Delhi: The government has waived off the requirement of mandatory testing of cough syrups in case manufacturers are exporting it to USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland in view of approval been granted by the regulatory authority of these countries for plants engaged in manufacturing and export of cough syrups, the new notification said.

Last year the government had made testing of cough syrups mandatory before export due to the alleged link of India-made cough syrups to the deaths of children in Gambia and Uzbekistan. According to the recent amendment in the export policy by the Directorate General of Foreign Trade (DGFT) if the cough syrups are manufactured in the plant or section approved by the regulatory agencies of these developed countries for any product, such cough syrup shall also be permitted to be exported to any country without testing as mandated earlier, the revised requirement suggested.

“The mandatory testing of the export sample of cough syrup under HSN 3004 is exempted in certain situations as mentioned above in accordance with the required GMP benchmarks/standards,” it said. ET has seen a copy of the notification.

Last year in May the DGFT had also notified that the exporters will have to also produce the certificate of analysis (CoA) from the government laboratory to be able to export cough syrups effective June 1.

“The export of cough syrup under ITC (HS) Codes falling under the heading 3004 shall be permitted subject to the export sample being tested and production of CoA issued by any of the laboratories with effect from June 1, 2023,” the earlier notification had said.

The intervention by the DGFT followed past incidents where India-made cough syrups imported into Gambia were allegedly found to be contaminated with diethylene glycol (DEG) and ethylene glycol (EG) resulting in Acute Kidney Injury (AKI) cluster among children.

An investigation led by the United States Center for Disease Control and Prevention and Gambian scientists in March “strongly suggested” that medications contaminated with DEG or EG imported into the Gambia led to this AKI cluster among children.

“A large cluster of acute kidney injury cases affecting children in The Gambia in 2022 was associated with case fatality rates of more than 80%,” it said.

The WHO had announced that the deaths of dozens of children in Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug manufacturer-Maiden pharmaceuticals.

The ‘Morbidity and Mortality weekly report’ published by the CDC, reached its conclusions by reviewing the medical records of 52 (67%) of the 78 identified patients with suspected AKI.

Source : Economic Times