Policy & Regulation DTAB recommends amendment of Rule 64 related to qualification of competent person for wholesale license Gireesh Babu, New Delhi Wednesday, October 23, 2024, 08:00 Hrs  [IST] The Drugs Technical Advisory Board (DTAB) has once again recommended the finalisation of the amendment of Rule 64 of the Drugs Rules, 1945, to restrict the qualification of the competent person eligible for holding the license for wholesale of drugs under Form 20B and 21B. The Board, in its latest meeting held in August, observed that the amendment was issued through a draft notification in December, 2016, after an earlier recommendation, but has not been finalised. The Rule 64 specifies the conditions to be satisfied before a licence in Form 20, 20B, 20F, 20G, 21 or 21B is granted or renewed. The second proviso to sub-rule (2) of this Rule specifies the requirements of the area and the qualification of the competent person for grant of licence in Form 20B and 21B. The existing rules specifies that the competent person should be a registered pharmacist, or one who has passed the matriculation examination or its equivalent examination from a recognised Board with four years' experience in dealing with sale of drugs, or one who holds a degree of a recognised university with one year's experience in dealing with drugs. The Board was considering a proposal to amend this proviso to restrict the qualification of the competent person to a person with pharmacy background only, such as D.Pharmacy, B.Pharmacy, M.Pharmacy and Pharm.D. As per the proposal, clause (b) and (c), which are related to other qualifications such as matriculation examination or its equivalent examination from a recognised board with 4 years' experience in dealing with sale of drugs, or degree of a recognised university with one year experience in dealing of drugs should be deleted from the Rules. The matter was earlier considered in a meeting held by the Board in August, 2015, and recommended that the clause (b) and (c) of the second proviso may be deleted and a protection clause may also be provided that the academic qualification shall not apply to the persons already registered prior to the date of final notification. A draft notification in this regard was published in December, 2016, but there were several issues raised from the stakeholders, due to which the said draft notification could not be finalised. The Board also said that "there was a concern about its desirability and accessibility." After examination of the stakeholders comments, the Central Government requested the Board to furnish comments and inputs in the matter. The DTAB, after looking at the matter, "again recommended for the finalisation of the Draft" for amendment of the Rule 64, "to strengthen the supply chain for ensuring the quality, safety and efficacy of drugs." It may be noted that the Central Drugs Standard Control Organisation (CDSCO) has constituted a committee for revisiting the Rule 64, under Part VI of the Drugs Rules, pertaining to sale of drugs other than homoeopathic medicines "with regards to the present scenario". The conditions of Rule 64 prescribes the conditions to be satisfied before a license in various forms related to sale of drugs is granted. The Drugs Consultative Committee (DCC), which advises the Centre and the States on the matters that requires uniform implementation across the country, has also recently asked the committee formed by the CDSCO to revisit the Rule 64 of Drugs Rules, 1945, and place its report before the DCC for further discussion and consideration.

PCI offers continuing education and skill development programmes to pharmacists

Our Bureau, New Delhi Wednesday, October 23, 2024, 08:00 Hrs  [IST]

The Pharmacy Council of India (PCI) has informed all State Pharmacy Councils that the council has initiated continuing education programmes and skill development programmes to improve the skill sets of the pharmacists across the country. The information has been passed to the State Councils to utilise the initiatives to improve the quality of manpower in the states. PCI has joined hands with Life Sciences Sector Skill Development Council (LSSSDC) for skill development and entrepreneurship under funding support from Pradhan Mantri Kaushal Vikas Yojana for Upskilling and Certification Programme of LSSSDC in Life Sciences Sector. The project has a total of 26,500 seats for the registered pharmacists for upskilling and certification by LSSSDC. This is a good opportunity for State Pharmacy Councils in the Southern Region to up-skill and certify the registered pharmacists for their future growth and enhance the skills for efficient performance in pharmacies. Initially, the project will start from southern states. Mandatory 30 hours including four hours for programme orientation and mock assessment practice, along with two-three hours for mandatory assessments and daily training hours is minimum two hours and maximum eight hours. This certificate will be issued after completion of course. Certificate is valid for renewal of registration under CEP, under regulation 4.2 of Pharmacy Practice Regulations, 2015, it added. Besides, the Council has launched an online certificate course on Rational Use of Medicines for registered pharmacists, under the continuous education programme, in collaboration with Translational Health Science and Technology Institute (THSTI). This is to enable the registered pharmacists to make the community aware to use the drugs rationally. This certificate will be issued after completion of course and is valid for renewal of registration under CEP, under the provisions of Pharmacy Practice Regulations, 2015.

As per Circular issued by CBIC, the return of expired medicine must be treated as a fresh supply. The retailer or wholesaler can return the expired medicine to the manufacturer. Issuance of Invoice is mandatory for the return of such expired medicine.

When expired medicines are returned to a wholesaler, they are treated as a fresh supply and are usually destroyed by the manufacturer:

• Manufacturer destroys the goods

  The manufacturer reverses the ITC that was used when the expired goods were received. The ITC that needs to be reversed is the one used when the goods were returned, not the one used when they were manufactured.
• Manufacturer purchases the goods

  If the goods are deemed a fresh supply, the manufacturer or wholesaler will purchase them. 

• Here are some other things to know about returning expired medicines:

The retailer or wholesaler must issue an invoice for the returned medicine. The invoice should include the value of the medicine at the rate it was originally purchased.

 An unregistered person can return expired goods by issuing a commercial document without charging tax.

A reverse distribution company can be used to coordinate the return process. The company sorts and batches the products, calculates the return credit value, and sends the credit to the pharmacy. 

• Expired medicines can be less effective or risky because their chemical composition or strength may have changed. Some expired medications can grow bacteria, and sub-potent antibiotics can fail to treat infections.  

The Drugs Controller General of India (DCGI) is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.

The Drugs Controller General of India (DCGI) is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.

Currently, there is a provision for licence exemption to manufacture and import Class A medical devices (non-sterile products) for marketing in the country and conformance to quality management system for manufacturing of such medical devices is not included in the existing rules.

The matter was discussed in a meeting of the Drugs Technical Advisory Board (DTAB), the country’s top technical advisory body on drugs and medical devices, held last month

For existing institutions offering a Bachelor of Pharmacy (B.Pharm) program, approval from the Pharmacy Council of India (PCI) is mandatory, but approval from the All India Council for Technical Education (AICTE) is not required: (2020) Is AICTE approval mandatory for B. Pharm? In compliance of the order dated 05.03. 2020 passed by the Hon'ble Supreme Court of India in Transferred Petitions (CIVIL) No 87-101 of 2014, for the existing institutions offering courses in Pharmacy Programme, approval of Pharmacy Council of India (PCI) is mandatory and AICTE approval is NOT required.

• PCI

  The PCI is a statutory body under the Ministry of Health and Family Welfare, Government of India. The PCI is responsible for approving B.Pharm courses and ensuring that institutions meet certain requirements, such as having adequate classrooms, laboratories, and staff facilities. 
  
• AICTE

  The AICTE is a statutory body that develops technical education in India. The AICTE created a model course curriculum for B.Pharm, which universities can use to frame their own syllabi. 

• For existing institutions that offer B.Pharm courses, approval from the PCI is mandatory, but approval from the AICTE is not.  

PCI should conduct comprehensive study on performance of pharmacy institutions: Prof GP Mohanta

Peethaambaran Kunnathoor, Chennai

Friday, October 18, 2024, 08:00 Hrs  [IST]

Since Pharmacy Council of India (PCI) is now the only regulator for pharmacy education in the country after AICTE’s discontinuation of jurisdiction over pharmacy, the PCI should conduct a comprehensive study about the importance and performances of all pharmacy institutions, and check whether they fulfill all the requirements for providing quality education, opines Prof. Guru Prasad Mohanta, former HoD at the Department of Pharmacy at Annamalai University in Tamil Nadu.

 

According to him, the majority of the private pharmacy colleges are working with poor-quality faculty members. The PCI is not providing training programmes for the beginner-teachers. When pharmacy education was under the regulation of both the PCI and the AICTE, the technical education council used to conduct orientation programmes and refresher courses for the teachers.

When the AICTE’s role was severed, these two training programmes ceased to exist, and the PCI did not want to take it forward. As a result, the fresh faculty members do not get any training programme. Mohanta said the teachers should be given training on how to teach the subjects and how to handle a classroom. They should also be updated with the latest developments in the subject also.

 

He said India has the largest number of pharmacists as well as the largest number of pharmacy colleges. At present, the domain of India’s pharmacy education includes 5,855 pharmacy education institutions, 93,336 faculty members and 360,072 students. Out of 5,855, 1,865 colleges are affiliated to various private universities and 1,911 colleges are working under state medical or health universities. Besides, there are four government universities and seven National Institutes of Pharmaceutical Education and Research (NIPERs) that run exclusive pharmacy courses. The number of pharmacy college-affiliated private universities is 24.

 

Every year, over three lakh pharmacy graduates and diploma holders are produced by Indian pharmacy institutions. But there is not an all-inclusive report of the importance, necessity and performances of these institutions available either with PCI or with any institution or any agency. Being the pharmacy education regulator, the PCI should come forward to conduct a survey study about the performances and necessity of this many pharmacy colleges functioning across India. Similarly, the study should also focus on the facilities available in each institution, and whether the college managements are complying with the norms of the pharmacy council guidelines with regard to infrastructure facilities, laboratory equipment and qualification of the teachers.

 

According to him, there are very few institutions functioning with properly qualified faculties. In the case of qualification and standard required for teachers, the PCI should amend the rules and ensure highly qualified people are playing the role of faculty members in institutions. If India has to produce well-qualified pharmacists, quality of education is a factor which can be delivered only by well-qualified teachers.

 

Going back, Prof Mohanta said, the PCI, considering the availability of sufficient qualified pharmacist workforce, the national education regulator, in 2019, put a moratorium on the opening of new pharmacy colleges for running diploma as well as degree courses in pharmacy for a period of five years from the academic year 2020-2021. However, on the intervention of college managements with high courts, the council had to withdraw the moratorium in the next academic year, and from that year on the number of institutions started to increase alarmingly. At the time of putting the moratorium, the number of pharmacy colleges in India was 3,000.

 

He pointed out that when the AICTE lost its jurisdiction over pharmacy education, it stopped all grants that were being given to pharmacy students and institutions in the form of scholarships and other benefits. He alleged further that the government assured the students of a GPAT scholarship for pharmacy students, but the PCI is not vigorously initiating steps for expediting it. 

 

In Tamil Nadu, the president of the state branch of the APTI, Dr V Sankar, and in Odisha, the principal of the Dadhichi College of Pharmacy in Cuttack, Dr Rajat Kumar Kar, have started faculty training programmes for pharmacy teachers in the absence of refresher courses by AICTE or PCI.

A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet.

A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet. This chilling projection underscores the urgent need to combat antimicrobial resistance (AMR) as a critical global health crisis. Conducted by the Global Research on Antimicrobial Resistance (GRAM) Project, the study is the first comprehensive analysis of AMR trends, outlining its alarming future impact.

Key Findings: AMR-Related Deaths on the Rise

The GRAM study reveals that over one million people died annually from AMR between 1990 and 2021. Even more concerning is the forecast for 2050, where nearly 2 million people are projected to die directly due to AMR each year—an increase of nearly 70% compared to 2022. Furthermore, AMR is expected to contribute to 8.22 million deaths annually by 2050, representing a 75% surge from the 4.71 million deaths recorded in 2022.

Age-Related Trends in AMR Mortality

• Children under five years old: Deaths declined by 50% between 1990 and 2021, yet AMR still poses a threat.
• Adults aged 70 and older: AMR-related deaths rose by over 80%, with this demographic expected to bear the brunt of the mortality burden by 2050.

While AMR deaths among young children are expected to halve by 2050, fatalities in older populations will more than double, highlighting the aging population’s vulnerability.

Global Health Implications of AMR

Antimicrobial resistance occurs when bacteria evolve and no longer respond to medications, rendering treatments ineffective. The consequences of unchecked AMR are far-reaching and devastating. AMR already claims more lives than HIV/AIDS and malaria combined, with 1.2 million direct AMR-related deaths in 2019 alone. By 2050, this figure will balloon to a total of 39 million deaths across all ages.

Geographic Disparities

AMR-related deaths will disproportionately affect regions such as:

• South Asia: Expected to account for 11.8 million deaths directly due to AMR between 2025 and 2050.
• Sub-Saharan Africa and Southern/Eastern Asia: These regions will also see significant rises in fatalities, driven by limited healthcare access and ineffective infection control measures.

Historical Data and Projections

The GRAM study analyzed 520 million records from hospital data, deathc ertificates, and antibiotic use across 204 countries and territories. Based on historical trends, AMR-related deaths have steadily increased since 1990, with 1.14 million deaths directly attributed to AMR in 2021.

AMR’s Most Common Culprits:

• Methicillin-resistant Staphylococcus aureus (MRSA): Deaths increased from 57,200 in 1990 to 130,000 in 2021.
• Carbapenem-resistant Gram-negative bacteria: Resistance to these antibiotics grew from 127,000 deaths in 1990 to 216,000 in 2021.

Without significant intervention, these pathogens and others will continue to fuel rising mortality rates.

The Urgent Need for Global Action

To mitigate the escalating AMR crisis, the study calls for a comprehensive global strategy focused on:

• Infection prevention and vaccination programs
• Minimizing inappropriate antibiotic use
• Research and development of new antibiotics targeting resistant bacteria
• Access to quality healthcare and antibiotic treatments

The Future of AMR: What Lies Ahead?

Based on current trends, AMR is expected to directly cause 1.91 million deaths annually by 2050, a stark 67.5% increase from 2021. In total, more than 39 million deaths will result directly from AMR between 2025 and 2050. However, with improved healthcare infrastructure and targeted development of antibiotics, an estimated 92 million deaths could be averted.

Key Solutions to Avert Catastrophe:

• Improved infection care: Particularly in regions like South Asia, sub-Saharan Africa, and Southeast Asia, better access to antibiotics could prevent millions of deaths.
• Innovation in drug development: The creation of new antibiotics targeting Gram-negative bacteria could save over 11 million lives globally by 2050.

Conclusion: A Call to Action

The findings from this study highlight the growing and evolving threat of antimicrobial resistance. Without prompt and coordinated efforts to prevent, manage, and treat infections caused by resistant bacteria, millions of lives will be at risk. Now is the time for governments, healthcare organizations, and researchers to intensify efforts to avert a global health catastrophe.