A case of coronavirus reinfection in Hong Kong confirmed by genome sequencing

Using genome sequencing, researchers at the University of Hong Kong have found a rare instance of reinfection with novel coronavirus for the second time, four-and-a-half months after the first infection. The first viral genome belongs to GISAID clade V, while the second genome belongs to GISAID clade G. Using genome sequencing, researchers at the University […]

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A case of coronavirus reinfection in Hong Kong confirmed by genome sequencing

Children have more coronavirus during early infection phase than hospitalised adults

Researchers found that children infected with novel coronavirus have viral load comparable with adults admitted to ICUs. But during the early infection phase, children can have significantly higher viral load than COVID-19 adults in ICUs. Viral load decreases over time in children. Age of children did not have any impact on viral load. Researchers Massachusetts […

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Children have more coronavirus during early infection phase than hospitalised adults

Intranasal vaccination of a coronavirus candidate vaccine prevents infection

A new vaccine candidate construct using chimpanzee adenovirus carrying the full length of novel coronavirus spike protein is able to achieve sterilizing immunity and prevent both upper and lower respiratory tract infection in mice when administered intranasally but not when given via the intramuscular route. A new vaccine candidate construct using chimpanzee adenovirus carrying […]

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Intranasal vaccination of a coronavirus candidate vaccine prevents infection — Science Chronicle

COVID-19: Saliva is a viable alternative to nasopharyngeal specimen in asymptomatic persons

In a mass-screening study of 1,924 asymptomatic persons, self-collected saliva samples had sensitivity (92%) and specificity (over 99.9%) comparable to nasopharyngeal specimens — sensitivity 86% and specificity over 99.9%. The true concordance probability between the nasopharyngeal and saliva tests was estimated at 0.998. In a mass-screening study of 1,924 asymptomatic persons using nasopharyngeal and self-collected […]

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COVID-19: Saliva is a viable alternative to nasopharyngeal specimen in asymptomatic persons

FDA approves rapid, inexpensive saliva test for coronavirus

A rapid, inexpensive saliva test developed by Yale School of Public Health in partnership with NBA has high sensitivity. The testing protocol has been made available through “open source”. The SalivaDirect test does not use any preservative at time of collection, uses commonly available reagents, and does not need equipment for nucleic acid extraction. In […]

FDA approves rapid, inexpensive saliva test for coronavirus

Buffers and Guidelines on the use of buffers in HPLC Methods

Medical Devices come in the category of drugs from the next financial year: Says Government notification

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare)
NOTIFICATION, New Delhi, the 11th February, 2020

Ministry of Health and Family Welfare (MoHFW) has brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulating them under the Drugs and Cosmetics Act (DCA). A gazetted notification to this effect has been issued on 11.02.2020 and the notification will come into effect from April 1.The move implies that any product used to treat a patient will come under the ambit of the DCA. Thus government will now have oversight on the medical devices industry and its activities in the country.A list of 37 devices has been drawn up and it includes syringes, needles, stents, catheters, intraocular lenses, intravenous cannulae, prosthetic replacements, ligatures, sutures, staplers, condoms, blood bags, nebulizers, blood pressure monitoring machines and digital thermometers. At present, only 23 medical devices have been classified as drugs. Of these, only a few including cardiac stents, drug eluting cardiac stents, condoms, intrauterine devices, have been brought under price control. Medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO). Such registration is voluntary for a period of 18 months, after which it will be mandatory. Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints. It can also cancel the license of a manufacturer if it finds lapses.

Further, it gives timelines for registration and regulation of devices. For low and moderate risk devices if is 30 months from date of commencement of the rules, while for moderate high risk and high risk devices it is a period of 42 months within which it would be brought under the new regulations.
The manufacturer or importer will have to upload the generic name, model number, intended use, class of medical device, material of construction, dimensions, shelf life and brand name on the online portal of the Central Drugs Standard Control Organisation, the notification states. Once the device is registered, the manufacturer or the importer will have to mention the registration number on the device. MoHFW has specified that all such devices including instruments, apparatus, appliances, implants or other articles, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specifically on human beings or animals, will be considered for this purpose. For registration refer registration of certain medical devices at CDSO website vide G.S.R. 102(E) dated 11.02.2020.

However, Industry lobby is not comfortable with this, and were hoping that Medical devices will be considered under separate act for which NITI Aayog was also doing work.

National Medical Devices Promotion Council

It took complete one years to set up National Medical Devices Promotion Council, after its initial announcement by then Minister of Commerce & Industry Mr Suresh Prabhu during 4th WHO Global Forum Meet on Medical Devices, at Andhra Pradesh Medtech Zone, in Vishakhapatnam. It will be headed by Secretary, Department for Promotion of Industry & Internal Trade (GOI). Now the Council is scheduled to hold its 1st meeting on January 14, wherein apart from Secretary DPIIT, there are 27 other members in the Council including NITI Aayog Adviser, senior officials from health ministry, National Pharmaceutical Pricing Authority (NPPA), MSME, Department of Biotechnology and representations from various stakeholders including industry associations. The agenda of the meeting would be deliberations on creation of regulatory structure for medical devices, considering the representations and grievances from the industry, discussion on trade margin rationalization and tariff protection for devices. Government intends to support the medical device industry in order to promote India as manufacturing hub for low priced quality products, like pharma sector.

Medical Devices Industry plays a critical role in the healthcare ecosystem. The manufacturing and trade in MDI is growing steadily which includes a wide range of products owing to increasing non-communicable diseases and hospitalization. Although the industry has been growing in double digits but is predominantly import-driven with imports accounting for over 70 % of the domestic market.

The mandate of this council would be creating an ecosystem by policy interventions to promote local manufacturing of quality medical devices so that India can reduce its imports from other countries and can generate revenue from exports of quality devices. Medical devices market in India is estimated to be $7 billion approx. Currently, US is the largest exporter of medical devices to India, constituting one-fifth of the total, Germany, China, Singapore and the Netherlands are among other major suppliers.

National Medical Devices Promotion Council will have the following objectives and activities :

  1. Act as a facilitating and promotion & developmental body for the Indian MDI.
  2. Hold periodic seminars, workshops and all related networking activities to garner views of the industry and understand best global practices in the sector and  deliberate on various parameters for inclusion in the industrial and trade policies in   medical devices.
  3. Identify redundant processes and render technical assistance to the agencies and departments concerned to simplify the approval processes involved in medical device industry promotion & development.
  4. Enable entry of emerging interventions and support certifications for manufacturers to reach levels of global trade norms and lead India to an export driven market in the sector.
  5. Support dissemination and documentation of international norms and standards for medical devices, by capturing the best practices in the global market and facilitate domestic manufacturers to rise to international level of understanding of regulatory and non regulatory needs of the industry.
  6. Drive a robust  and dynamic Preferential Market Access (PMA) policy, by identifying the strengths of the Indian manufacturers and discouraging unfair trade practices in imports; while ensuring pro-active monitoring of public procurement notices across India to ensure compliance with PMA guidelines of DPIIT and DoP.
  7. Undertake validation of Limited Liability Partnerships (LLPs) and other such entities within MDI sector, which add value to the industry strength in manufacturing to gain foothold for new entrants.
  8. Make recommendations to government based on industry feedback and global practices on policy and process interventions to strengthen the medical technology sector, including trade interventions for related markets.

Buffers and Guidelines on the use of buffers in HPLC Methods

A buffer solution is a solution that resists changes to a solution’s pH, when small quantities of acid or alkali are added to the solution.

Use of buffer plays an important role in HPLC separation, change can separate two closely eluting peaks and may merge two separate peaks. The most commonly used buffers in LC are citrate, acetate and phosphate buffer.

Choosing the right buffer

Many factors can influence the choice of the buffer, points to be taken into consideration for selecting the right buffer:

  • Required pH of mobile phase
  • The UV cut-off value
  • A volatile buffer should be used for MS-based chromatography.

Buffer pH

pH plays an important role in determining retention time and shape of the peak. A silica-based column should not be used for buffer solutions with Very low pH and High values; as at low pH stationary phase bond may get removed and there is chance of silica getting dissolved in high pH.

Buffer Solubility and Concentration

Buffer solubility and concentration play a vital role in method development. The best buffer is the one that is fully soluble and gives reproducible result at the lowest concentration. Higher buffer concentration may increase the viscosity and precipitation of the buffer which may lead to backpressure.

Preparation of buffer solutions: Weigh the required quantity of buffer in the volumetric flask and then add solvent as required. Adjust the pH of the solution and then fill the flask to the mark. Sonicate the buffer solution for complete degassing of the solution. Add the organic phase and filter the mixture with 0.45µm filter or 0.22 µm based upon the requirement of its application.

Total Quality Management in Pharmaceutical Industry

Introduction: Total Quality Management is a systematic approach for the continual improvement of all Organization processes, through the participation of all the staff, leading to prime quality product and services to achieve customer satisfaction
It is supported by the philosophy: “Do the right things, right first time, every time”.

Principles of Total Quality Management: The principle of TQM serves as the basis of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) required by most regulatory bodies.

1. Customer-focused: The customers are the end-user of the product or medicines and therefore all the methods and policies ought to be created keeping in mind customer’s necessities and safety as outlined by the standards or regulators.

2. Staff Involvement: All employees should participate and work towards common goals. The goal of an organization shall be clearly defined in the management documents.

3. Process-centered: The focus of the process is to improve the quality of the output that is the final product. The process follows collecting inputs from all the people involved at each step of the process and converting it into quality output by continual improvement of internal practices. This approach of TQM holds all the parties involved in the production process accountable for the overall quality of the final output (services or product).

4. Integrated system: Integration of system means creating a single organizational structure in which all the subsystem maintains its purpose and integrity. The main objective of an integrated system in the pharmaceutical industry is to create a joint documented subsystem for quality management, risk management, occupational health and safety, project management, etc., so that they can function as a unit combining interactive and interrelated processes and directs the work of its divisions to achieve the goal of the company.

5. Strategic and systematic approach: All the processes are to be managed as one coherent quality management System.

6. Continual improvement: keeping in mind changing market trends and stringent regulatory requirements. Continuous improvement in process and quality is a must requirement to meet the specification and regulatory requirements.

7. Fact-based decision-making: In order to succeed organizations need to establish evidence-based decision-making. This can be achieved by taking inputs from multiple sources, analyzing data, examining cause/effect, and considering potential risk.

8. Communications: Communication is defined as the exchange of information and understanding between two or more persons or groups. The main concept of TQM is the achievement of quality standards in products and services. This achievement is possible through effective communication.

Benefits of TQM when applied consistently over the period it helps in:

• Boost morale of all the people involved in the process
• It helps in cost reduction
• Increase Customer satisfaction
• Decrease in product recall

TQM works best in an environment where there is strong support from management.

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