15-Jul-2020: Market approval for Pneumococcal Polysaccharide Conjugate Vaccine given by DCGI
Drug Controller General of India (DCGI) has given approval to the first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine. This vaccine has been developed by M/s. Serum Institute of India Pvt. Ltd, Pune. Serum Institute first obtained the approval of DCGI to conduct Phase I, Phase II and Phase III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine in India. These trials have since been concluded within the country. The said Company has also conducted these clinical trials in another country i.e. Gambia.
Thereafter, the said Company applied for approval and permission to manufacture this vaccine. The application along with the clinical trial data has been reviewed by the Office of Drug Controller General of India with the help of Special Expert Committee (SEC) for vaccines. The Committee recommended for grant of permission of market authorization to the said vaccine. On 14/07/2020, M/s. Serum Institute of India Pvt. Ltd, Pune has been granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine. This is the first indigenously developed vaccine in the field of pneumonia. Earlier the demand of such vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India.
This vaccine is used for active immunization against invasive disease and pneumonia caused by “Streptococcus pneumonia” in infants. The vaccine is administered in a intramuscular manner.
11-Jul-2020: DCGI gives nod for restricted emergency use to Itolizumab for moderate to severe COVID-19 patients
Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency Use authorisation by the Drugs Controller General of India (DCGI) based on clinical trials data.
M/s Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name Alzumab. This indigenous drug has now been repurposed for COVID-19.
M/s Biocon has presented the Phase II clinical trial results generated in COVID-19 patients to DCGI. The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office.
Details of primary endpoint of mortality, other key endpoints of lung function such as improvement in PaO2 and O2 saturation were presented. Key inflammatory markers IL-6, TNFα etc., were presented to have reduced significantly with the drug thereby preventing hyper- inflammation in COVID-19 patients.
After detailed deliberation and taking into account the recommendations of the Committee, DCGI has decided to grant permission to market the drug under Restricted Emergency Use of the drug for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients due to COVID-19, subject to some conditions like informed consent of patients, a risk management plan, to be used in hospital set up only etc.
The average cost of treatment with this indigenous drug i.e. Itolizumab is also lesser than comparable drugs which are part of the “Investigational Therapies” indicated in the Clinical Management Protocol for COVID-19 of the Ministry of Health and Family Welfare.
29-Jun-2020: DCGI nod for human trials of ‘Covaxin’
The Drug Controller General of India (DCGI) has permitted human clinical trials of ‘Covaxin’.
It is India’s first vaccine candidate for COVID-19. It has been developed by Bharat Biotech (Hyderabad-based vaccine makers) in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
COVAXIN is an inactivated vaccine, created from a strain of the infectious SARS-CoV-2 virus, that has shown promising results in preclinical studies, demonstrating extensive safety and effective immune responses.
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. Now, approval has been given for the Phase I and II human clinical trials.
6-Feb-2020: Centre persists with ‘toothless’ pharma codes
Despite several instances of breach of the voluntary Uniform Code of Pharmaceutical Marketing Practices (UCPMP) by pharma companies, and the demand from the Indian Medical Association (IMA) and doctors to make it mandatory, the Department of Pharmaceuticals (DoP), which comes under the Ministry of Chemicals and Fertilizers, has yet again requested companies to abide by UCPMP.
It is noted that rather than taking steps towards instituting statutory regulation of unethical marketing and promotion, the DoP is still requesting companies to abide by a toothless, unenforceable UCPMP. Pharma associations are requested to make sure that the pharma accompanies adhere to the provisions of UCPMP and no unethical promotion of pharma products be done during the conference. DoP is yet to make compliance under the UCPMP compulsory.
Uniform Code of Pharmaceutical Marketing Practices (UCPMP):
- India does not have a specific law at present that regulates the promotion and marketing of drugs and medical devices by companies before health care practitioners (HCPs).
- Advertisement of drugs and medical devices to end consumers, on the other hand, is heavily regulated.
- The Central Government had published a set of guidelines in December 2014 called Uniform Code of Pharmaceutical Marketing Practices (UCPMP) as guidance to the industry for promotion and marketing of drugs and medical devices. However, these guidelines are voluntary and do not have the force of law, at present.
- The government is contemplating a separate code for the promotion of medical devices called the Uniform Code for Medical Device Marketing Practices (UCMDMP). However, the code has not yet been finalized.
- Until UCMDMP is officially published, the UCPMP should be treated as the official guidance for the promotion of medical devices by medical devices companies.
15-Aug-2019: What is a notifiable disease?
A month after Union Health Minister Dr Harsh Vardhan asked the Delhi government to make malaria and dengue notifiable diseases, the South Delhi Municipal Corporation (SDMC) has initiated the work to notify malaria in the capital.
A notifiable disease is any disease that is required by law to be reported to government authorities. The collation of information allows the authorities to monitor the disease, and provides early warning of possible outbreaks. The World Health Organization’s International Health Regulations, 1969 require disease reporting to the WHO in order to help with its global surveillance and advisory role.
Making a disease legally notifiable by doctors and health professionals allows for intervention to control the spread of highly infectious diseases. Registered medical practitioners need to notify such diseases in a proper form within three days, or notify verbally via phone within 24 hours depending on the urgency of the situation. This means every government hospital, private hospital, laboratories, and clinics will have to report cases of the disease to the government.
The process helps the government keep track and formulate a plan for elimination and control. In less infectious conditions, it improves information about the burden and distribution of disease.
The Centre has notified several diseases such as cholera, diphtheria, encephalitis, leprosy, meningitis, pertussis (whooping cough), plague, tuberculosis, AIDS, hepatitis, measles, yellow fever, malaria dengue, etc.
The onus of notifying any disease and the implementation lies with the state government. Any failure to report a notifiable disease is a criminal offence and the state government can take necessary actions against defaulters.