New Delhi:

The Union Health Ministry on Thursday said media reports stating that India has a high number of ‘zero dose children’, who did not receive any vaccine, in comparison to other countries based on UNICEF report depicts an incomplete picture of the country’s immunization data.

The ministry said they do not factor in the population base and immunization coverage of the countries compared.

The accurate and complete narrative of the immunization efforts of the government can be gauged through comprehensive understanding of the relative data and programmatic interventions, the ministry added.

The percentage coverage for all antigens in India is higher than the global average.

In India, for most of the antigens, the coverage is more than 90 per cent, which is at par with other high-income countries such as New Zealand (DTP-1 93 per cent), Germany and Finland (DPT-3 91 per cent), Sweden (MCV-1 93 per cent), Luxembourg (MCV-2 90 per cent), Ireland (PCV-3 83 per cent), United Kingdom of Great Britain and Northern Ireland (RotaC 90 per cent).

Even if India’s coverage of 83 per cent is compared for Pneumococcal Conjugate Vaccine (PCV), which falls at the lowest bracket, it is much higher than the global figures of 65 per cent.

Among the compared countries, India is the only country having DTP-1 (Penta-1) coverage above 90 per cent and dropout children i.e., those that receive a first but not the third dose of DTP (Penta), are 2 per cent whereas this gap is much wider in other compared countries. These figures are clearly reflective of focused programmatic interventions in the country within the folds of its wide socio-geographically diversity, the ministry said in the statement.

The number of zero dose children in India account for 0.11 per cent of the country’s total population, it stated.

These statistics reflect the unwavering commitment of the Government to continuously increase the scope and reach of the immunization program of the nation.

The country’s Universal Immunization Programme is the largest public health initiative, targeting a massive cohort of 2.6 crore children and 2.9 crore pregnant women annually through 1.2 crore vaccination sessions.

The Full Immunization Coverage for FY 2023-24 stands at 93.23 per cent nationally. With consistent efforts to reach and vaccinate all eligible children against vaccine preventable diseases, the country has been able to achieve a noteworthy reduction in the Under-5 Mortality Rate (U5MR) declining from 45 per 1000 live births in 2014 to 32 per 1000 live births (SRS 2020).

In addition, India has widened the basket of vaccines with the introduction of six new vaccines under the UIP to increase breadth of protection since 2014, the statement said.

To reach out to zero dose and under vaccinated children, India has implemented initiatives under Mission Indradhanush and Intensified Mission Indradhanush with the support of the States. This has resulted in the reduction in the number of zero dose children by 34 per cent between 2014-2023.

Since 2014, 12 phases of Mission Indradhanush have been conducted across all districts wherein 5.46 crore children and 1.32 crore pregnant women have been vaccinated across all phases.

India provides maximum number of WHO recommended vaccines under the UIP in comparison to most of the other countries. The mean coverage for India is 83.4 pc, which is more than 10 percentage point of the global coverage.

With high level of coverage of OPV and IPV, India has successfully maintained 13 years of polio-free status since the last polio case was detected in 2011.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

New Delhi:

The Union Health Ministry has issued guidelines for the ethical use of “leftover, de-identified and anonymous” samples generated from a diagnostic or surgical procedure on patients for commercial use.

These specimens include organs, parts of organs, cells, tissues, cell products such as blood, blood products (even positive for eHBsAG/HCV/HIV/Syphilis and expired blood), urine, saliva, DNA/RNA, hair, nail clippings, or any other cells, body fluids etc.

The source for these specimens may be patients, autopsy specimens, abandoned wastes, tissue banks, IVF clinics and organ donation centres among others, the health ministry said recently.

After these samples have undergone the required clinical and laboratory testing for the patient, there are large quantities of leftover samples that may remain available in the hospitals.

These samples may be referred to as biomedical waste, sometimes maybe a biohazard, and require appropriate disposal methods, the ministry said.

The hospital itself may have no added value for these samples, nor the capacity to store these samples after the provision of patient care. Such samples are usually discarded as hospital waste, it stated.

According to the ‘Guidelines for Ethical use of Leftover de-identified/ Anonymous Samples for Commercial Purpose’, these leftover samples if de-identified or anonymous can serve as a precious resource for research and development activities to develop diagnostics, advance innovations, or for the development of kits, identify specific disease markers, or determine relevant health parameters and other such purposes and may have huge value.

“There has been keen interest from commercial companies in procuring and using the leftover and de-identified samples for the development of commercial kits/products or technologies that have the potential to improve future patient outcomes, provide diagnostic accuracy, or offer therapeutic advancements ultimately benefiting society,” the guidelines said.

It, however, underlined that the hospitals must ensure the samples are completely anonymous and de-identified irreversibly or non-identifiable materials or leftover biological samples which are not specifically intended for research purposes and are going to be discarded after clinical diagnostics or care.

These could be pooled samples or samples without any traceable/ or without any identifiers that could potentially lead back to the patient.

Robust data security measures must be in place to protect any residual information associated with the samples. Companies should maintain transparent and open communication with the relevant institutions and hospitals, the guidelines stated.

“Commercial kits and technologies that are prepared should be affordable, ensuring broader accessibility for patients and healthcare providers in the country,” it stressed.

The patients own the biological samples and data collected and the institutions are the custodians acting on their behalf and as per ICMR National Ethical Guidelines, 2017, informed consent is required from the patients for any secondary use of samples for ‘research’.

However, if the clinical samples are anonymous or de-identified irreversibly or left over after clinical care, they lose identity and there is no way for the institutions to go back to patients to obtain informed consent for any secondary use, the guidelines said.

“Therefore, for the use of deidentified/ anonymous leftover samples, use may be permitted with a ‘waiver of informed consent’.” the guidelines said.

There would be no loss to the patient’s rights or autonomy in such cases as the left-over samples are de-identified and cannot be traced to the patient.

The guidelines emphasized that de-identified samples that contain clinical information could still become identifiable and, therefore, could lead to a breach in the confidentiality of the patient.

“If the samples are identified/coded/ can be reversible to identify the patient, and samples are not leftover, samples contain clinical/personal information or they are research samples this guideline will not be applicable,” it stressed.

Companies must adhere to local, national, and international regulations governing the collection, storage, and secondary use of biological samples.

This includes obtaining necessary approvals such as ethical clearance as well as establishing formal agreements such as MoUs or MoA and MTAS.

In case of deviation, violation of regulations and disputes between parties, government regulatory agencies take action through appellate bodies like the High Court or the Supreme Court.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

A view shows the plenary session of the Summit on Peace in Ukraine, in Stansstad, Switzerland, June 16, 2024.
| Photo Credit: Reuters

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New Delhi:

The Ministry of Health and Family Welfare has issued a statement refuting recent media reports that suggest a shortage of anti-Tuberculosis (TB) drugs in India and question the efficacy of these drugs under the National TB Elimination Programme (NTEP).

The ministry has labelled these reports as vague and ill-informed, lacking specific information about the availability of anti-TB medicines in stock, read the Ministry of Health and Family Welfare press release.

Under the National TB Elimination Programme (NTEP), the treatment for drug-sensitive tuberculosis involves a regimen of four drugs available as 4 FDC (Isoniazid, Rifampicin, Ethambutol, and Pyrazinamide) for two months, followed by three drugs available as 3 FDC (Isoniazid, Rifampicin, and Ethambutol) for an additional two months.

Importantly, there are sufficient stocks of all these drugs, with supplies lasting for six months or more.

For Multi-Drug Resistant TB, the treatment typically consists of four months of seven drugs, followed by five months of four drugs. In approximately 30 per cent of cases of drug-resistant TB, cycloserine and linezolid may be required, read the press release.

The procurement, storage, and distribution of anti-TB drugs and related materials are centrally managed under NTEP. In rare cases, states were requested to procure specific drugs locally for a limited period to ensure that individual patient care remains uninterrupted.

For instance, Maharashtra has procured Cycloserine Tablets centrally, and some states have delegated procurement to districts as needed.

The Ministry shared the current stock status of anti-TB drugs in Maharashtra and at the national level to dispel any doubts about shortages.

Stock Position at National Level (as of September 24, 2023)- Cycloserine – 250 mg: 14,79,857 units, Linezolid – 600 mg: 9,95,779 units, Delamanid – 50 mg: 11,37,802 units, Levofloxacin – 250 mg: 28,85,176 units, Levofloxacin – 500 mg: 33,27,130 units, Clofazimine – 100 mg: 12,86,360 units, Moxifloxacin – 400 mg: 2,72,49,866 units, Pyridoxine: 2,72,99,242 units, read the press release.

The ministry emphasises that there is no shortage of essential anti-TB drugs, with over 15 months of stock available for Moxifloxacin 400 mg and Pyridoxine under NTEP.

Additionally, Delamanid 50 mg and Clofazimine 100 mg were procured in August 2023 and supplied to all states and Union Territories.

Purchase orders have been issued for the supply of Linezolid-600mg and Cap Cycloserine-250 mg in August 2023, with these drugs being dispatched to the states.

The Ministry of Health and Family Welfare assures that significant efforts are in place to ensure the availability of these crucial anti-TB drugs, with regular assessments conducted to evaluate stock positions at various levels, from central warehouses to peripheral health institutes.

Therefore, the media reports are deemed vague and ill-informed, not accurately reflecting the actual stock of anti-TB drugs in the country.

Thursday evening saw the end of a half-month stand-off between the National Medical Commission (NMC), India’s regulatory body guiding medical professionals and the Indian Medical Association (IMA), a national voluntary organisation of physicians with over three lakh members.

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The two had locked-horns over one of the provisions of the NMC’s notification on August 2 asking registered medical practitioners (RMP) to prescribe generic medicines only. The Health Ministry now seems to have bought time for both parties.

In its latest notification the NMC has suspended proposed regulations until further notifications. “The NMC Registered Medical Practitioner (Professional Conduct) regulations, 2023 are hereby held in abeyance with immediate effect,’’ noted the Commission.

Said Dr. Sharad Agarwal, national president, IMA: “This is a grand victory as the entire regulations have been held in abeyance. Medical community has prevailed for the good of the people.’’

The previous NMC’s Ethics and Medical Registration Board notification reads: “Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.’’

The IMA had demanded its withdrawal stating that it should not be enforced till there is assurance that the medicines meet quality standards.

Generic is much cheaper

Explaining its stand the Commission has said out-of-pocket spending on medication remains very high, and with generic medicines being 30 % to 80 % cheaper than branded drugs, prescribing generic medicines may bring down health care cost and improve access to quality care.

The IMA on the other hand raised objection to this provision in the notification and expressed their fear that the alleged poor quality of generic medicines available in India would adversely impact patient health and treatment. They even met with Union Health Minister Mansukh Mandaviya to put across their strong objection. The other arguments against the move include – leaving sales in the hands of chemists in an ecosystem where generic medicines available have wildly varying MRP and huge profit margins on the same combination drugs manufactured by different companies. Unregulated proliferation of pharma companies making generic drugs and lack of choice for patients are also fears.

Even though doctors were required to prescribe generic drugs earlier, there are no penal provisions mentioned.

The suspended notification, however, said that case of violations, a doctor may be given a warning to be more careful about the regulations or instructed to attend a workshop or academic programme on ethics, personal and social relations, and/or professional training and on repeated violations, the doctor’s license to practice may be suspended for a particular period.

K. Senthil, State president, T.N. The Government Doctors Association said that this was not a new idea: a proposal to prescribe generic drugs has existed since 2016. “The only difference now is the quantum of punishment prescribed,” he said.

Pharmacists can choose

The problem, he explained, was that even if doctors did give generic drug prescriptions, pharmacists/chemists were under no such obligation and could give branded drugs to patients. “Also, prescribing combination drugs is not possible through generics,” he said.

On quality of drugs, he pointed to the dismal shortage of manpower in most States in the Drug Controller’s offices, and asked how it was possible to ensure good quality drugs in such a situation. Drugs available in India fall under the following categories – branded under-patent drugs, branded generic (a branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different companies’ brand names. These drugs may be less costly than the branded patent version but costlier than the bulk-manufactured generic version of the drug) and lastly generic drugs. Generic drugs are defined as a “drug product that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use”.

There is less regulatory control over the prices of these “branded” generic drugs and this is also what has the doctors worried and they warn that any change in drug — especially for patients with chronic illnesses and critical care — may mean patients do not get the full benefit of a particular drug. There is no concrete evidence to show that generic drugs are equal to branded drugs, with respect to bioavailability, potency, efficacy, and impurity content.

There can be complications and some of the ailments and diseases can go out of control, doctors argued.

Quality is an issue

Pointing out that the bioavailability of a generic drug molecule is not assured by quality control or clinical trials, C.N. Manjunath, director of the state-run Sri Jayadeva Institute of Cardiovascular Sciences and Research, said the very fact that the same company that is manufacturing a branded drug also manufactures a generic drug means that there is a shift in quality.

He said one should not compromise on the quality of drugs, particularly in the critical care sector, including cardiac emergencies. Sundar Sankaran, who formerly headed the Indian Society of Nephrology (Southern Chapter) said maintaining stable drug levels in transplant recipients is vital. “Branded drugs and non-branded generic drugs may have variations in their formulation and potency which can potentially affect drug levels and outcomes for transplant patients. Lifesaving drugs like Tacrolimus and cyclosporine, which have a narrow therapeutic window, require careful monitoring and consistency in brand usage. Swapping between different generic brands could lead to variations in drug levels, putting the transplanted kidney at risk,” said the doctor, who is also the Director of Aster Institute of Renal Transplantation in Bengaluru.

Rajeev Jayadevan, member, Public Health Advisory Panel, Kerala State IMA, adds that the primary aim of the doctor is to ensure the complete recovery and well-being of the patient. Doctors’ prescribing patterns are established through years of practice and patient feedback. This is a relationship no pharmacy or medical shop can have with patients. “When only a generic name is written on the prescription, even if a better quality version is available, the pharmacy salesperson will be encouraged to dispense those products with the highest profit margin. The quality control, storage, distribution and dispensation of drugs is not yet uniform in the country which is the main area of concern for doctors. If this is worked out — generic medicines will work well in India,’’ he said.

Rules for prescribing

NMC had in its notification also listed out the manner in which prescriptions have to be made and stated :”Prescribe drugs with generic, non-proprietary, pharmacological names only but in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed.

“Prescribe drugs rationally and optimally, both overprescribing and under prescribing are to be avoided keeping in mind possible drug interactions and fixed-dose combinations are to be used judiciously. Besides this only approved and rational fixed-dose combinations are to be prescribed,’’ NMC has noted.

It also advised hospitals and local pharmacies to stock generic drugs, prescribe only those generic medicines that are available in the market and accessible to the patient, avoid prescribing “branded” generic drugs and encourage patients to purchase drugs from Jan Aushadhi Kendras and other generic pharmacy outlets.

In the recently concluded G-20 health summit the Health Ministry maintained that for India — healthcare is not just a sector, but a mission and that the country is currently supplying around 60% of the world’s vaccine needs and 20-22% of generic exports. Its $50 billion drug-manufacturing industry exports medicines to over 200 nations, as per some reports.

Committed to affordability

“The country is dedicated to providing affordable, high-quality drugs and contributing to global accessibility,’’ Union Health Minister Mansukh Mandaviya said while speaking alongside Ernst Kuipers, Health Minister of the Netherlands. He said medicines manufactured in India saves lives in Netherlands, in Europe and across the world.

Budi Gunadi Sadikin, Indonesian Health Minister, added that India’s Jan Aushadhi Kendra model is the best in the world in terms of providing quality, accessibility and affordability of medicines to the people.

Also just last month the Health Ministry directed regulatory authorities to conduct risk-based inspections and audits of manufacturing plants adding that Schedule M shall be made compulsory for the Micro, Small and Medium Enterprises (MSME) pharma sector in a phased manner. The move is aimed at helping in quality assurance and reduce compliance burden. Schedule M of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ that should be followed by pharmaceutical manufacturing units in India.

Meanwhile, individual doctors and healthcare activists have expressed their views on the stand-off between NMC and IMA. In a social media post S.P. Kalantri, director professor of MGIMS and Medical Superintendent of Kasturba Hospital said: “The NMC’s bid to cut links between medical professionals and the pharma industry is sending shockwaves through India’s healthcare. But is this strict approach the solution? Bioequivalence testing is important because it shows that a generic drug works the same way as the original one tested in trials. Hence, should every drug—be it generic or branded—go through this before hitting the market? Is the NMC’s proposal too ambitious? Is it possible to untangle deep-rooted ties between doctors and the drug world?

Gopal Dabade, president of Drug Action Forum, Karnataka, said: “we welcome the NMC notification. Use of generic drugs will make healthcare affordable and cut out of pocket expenses for patients.’’ Disputing claims by the medical fraternity that switching to generic drugs may harm the patients, he said there was no scientific evidence to prove this.

(With inputs from Afshan Yasmeen in Bengaluru, Zubeda Hamid in Chennai and C. Maya in Tiruvananthapuram)

Bindu.p@thehindu.co.in