PHARMA LITERATI

With the central drug regulator now planning to regulate all medical devices under Drugs and Cosmetics (D&C) Act in a phase wise manner, the Union health ministry is planning to upgrade manpower at Central Drugs Standard Control Organisation (CDSCO) towards effective licensing and enforcement activities to ensure safety, quality and performance of medical devices. Considering that bringing all medical devices into regulatory control will lead to increase in work load considerably, a total of 754 CDSCO regulatory officers and laboratories staff will be inducted into the existing manpower of 119 regulatory and lab staff at CDSCO before implementation of the second phase. As per the road map outlined till 2020, the ministry has set out to upgrade CDSCO manpower by creating additional 1,195 new posts, including 64 experts, and additional 4,300 personnel for new laboratories, mobile drug testing labs, e-governance and training. CDSCO has...

Although the Delhi government has made it mandatory that degree should be the minimum qualification for pharmacist post, all other state governments in the country need to replicate the policy so as to force the central government to bring in a rule in the same direction at the national level, according to the national organizing secretary of All India State Government Pharmacists Association (AISGPA). In a telephonic interview with Pharmabiz, M Vijayalakshmi, a working pharmacist under Karnataka government and the organizing secretary of AISGPA said the professional services of government pharmacists in India need to be streamlined for which there should be some amendments in the policies and recruitment rules (RR). The RR should have a federal structure applicable to all states and union territories uniformly. Similarly, the pattern of promotional cadres for pharmacists should also be same in every state. The national organisation was formed to coordinate all state associatio...

Ophthalmologists are now alarmed over the increasing UV (ultraviolet) radiation in summer which is manifesting eye disorders across all age groups. The effect of climate change and an evolving El Niño have added to an upswing in temperature. UV rays can result in progression of cataract and age related macular degeneration besides eye allergies. “ UV radiation comprises invisible high energy rays that lie just beyond the violet/blue end of the visible spectrum. More than 99% of UV radiation is absorbed by the anterior structures of the eye, although some of it does reach the light-sensitive retina. Ultraviolet radiation can play a contributory role in the development of various ocular disorders including age-related cataract, pterygium, photokeratitis and corneal degenerative changes, and age-related macular degeneration ", said Dr. Raghu Nagaraju, General Ophthalmology, Cornea & Refractive Surgery, Dr. Agarwal’s Eye Hospital, Bengaluru. For good eye health during...

Diplomat Pharmacy, Inc, is expanding its strategic relationship with medication adherence company SMRxT, creator of the Nomi system. Nomi, is a medication adherence system that uses real-time data and communications to improve patient outcomes. Nomi accurately captures multiple data points from patients, in real-time, to monitor how and when they take their medication. The system then translates patient behaviour into actionable information for patient interventions and engagement. Nomi sensor technologies record when a patient takes their medication, including the number of tablets. Real-time reporting gives healthcare providers the insight to manage patient adherence challenges. Diplomat is now integrating data from Nomi into its end-to-end pharmacy operating system. This will enable a more fully integrated approach to medication adherence and patient engagement. " We saw an opportunity to expand our patient care model by adding technology ," said Gary Rice, ...

The US Food and Drug Administration (FDA) announced the launch of a new education campaign to help Americans understand the important role they play in removing and properly disposing of unused prescription opioids from their homes. This new initiative is part of the FDA’s continued efforts to address the nationwide opioid crisis and aims to help decrease unnecessary exposure to opioids and prevent new addiction. The “Remove the Risk” campaign is targeting women ages 35-64, who are most likely to oversee household health care decisions and often serve as the gatekeepers to opioids and other prescription medications in the home. “The epidemic of opioid addiction and overdose is one of the greatest public health tragedies we’re facing as a nation, and no community is immune ,” said Amy Abernethy, M.D., principal deputy commissioner at the FDA. “We know that many people who misuse prescription opioids report getting them from a friend or family member. If every household removed pre...

The government of Delhi has made Bachelor of Pharmacy (B Pharm) the basic educational qualification for pharmacist post in government services. Besides, it has also approved three cadre structures for promotional avenues for the pharmacists. The Delhi government has issued a gazette notification dated 29.03.2019 in this regard. The newly approved three cadre structures are pharmacist, senior pharmacist and assistant chief pharmacist (ACP). Upgrading of basic qualification and creation of cadre structure were the long standing demands of various pharmacist associations in north India, except Bihar where most of the registered pharmacists are diploma holders. The government’s decision has come in the wake of a Central Administrative Tribunal order of 24 April 2012 which was kept in abeyance by the government for seven years without taken for implementation. In the meantime, the petitioner, Pharmacy Graduates Welfare Association (PGWA), New Delhi filed a contempt petition bef...

The Union health ministry will soon notify the medical devices like surgical gowns, surgical drapes and incision drapes as 'drugs' under Section 3(b)(iv) of the Drugs & Cosmetics (D&C) Act, 1940. Medical devices are defined as ‘drugs’ under the D&C Act for the purpose of regulating prices and quality control and also for regulating under the Medical Device (MD) Rules 2017. The proposal to add these devices to the notified list was approved by the 82nd Drugs Technical Advisory Board (DTAB) at its meet recently. Once a medical device is notified, manufacturers and importers will have to get the regulatory body’s nod to sell these products in the domestic market.  In this connection, a public notice was uploaded on Central Drugs Standard Control Organisation (CDSCO) website dated 27 November 2018 for stakeholders review/suggestions within 45 days of the issue of the notice. This was followed by DTAB approval in March this year for the regulation of surgical drapes...

Coming out with a clear and actionable National Health Agenda, as envisioned by Indian political leadership, is a move in the right direction and will equip the new government to expedite the promises for achieving the goal of universal health coverage, according to NATHEALTH. National Healthcare Agenda includes empowering people with healthcare for all, higher spending, creating one medical college in each district, scaling up Ayushman Bharat and creating a robust health system for all. The industry will continue to collaborate to create a new and robust healthcare ecosystem.  The Indian healthcare industry has been collaborating with the government at all levels to push efforts for achieving the goal of ‘Health for All’. However, a comprehensive National Health Agenda would certainly provide a fresh impetus for creating a new healthcare system. A comprehensive health agenda needs active support from private sector which is playing a critical role in providing access...

The proposal put forward by the president of the Pharmacy Council of India (PCI) in the national pharmacy conference held in Guwahati in March this year towards forming a Confederation of all pharmacist associations in India will be realized shortly in the national level. An ad hoc committee meeting of all available office-bearers of associations will be held in another three months in Delhi, sources informed. Foundation work for bringing all associations into the national alliance is progressing and by the end of this year the confederating work and building of by-laws will be completed, says Birendra Kumar Burman, national convener of the proposed body. In a telephonic interview with Pharmabiz, Burman, a pharmacist-cum-lawyer from Guwahati said the proposal for a national confederation of pharmacists’ by Dr B Suresh, president of PCI, was highly appreciated by dignitaries of all sections of pharmacy, and regulatory officers and pharmacy intellectuals from across the nati...

Citing duties of pharmacists as clinical in nature and post of a pharmacist in a hospital a full time one, the Central Government Health Scheme (CGHS) pharmacists welfare union has urged the Union Health Ministry to pay them 20% of the basic salary as Non-Practicing Allowance (NPA) as is given to the doctors. In a letter written to the union health secretary, the Chennai branch secretary of the association has stated that as per the Pharmacy Practice Regulations 2015, a clinical pharmacist is eligible to draw non-practicing allowance. Besides, since the pharmacist is posted against a full time post, he is entitled to demand the NPA. Thirdly, as a government employee in whose case there is ample scope for private practice, the pharmacist is eligible to draw the allowance. The secretary of the union said as per PPR 2015, a pharmacist can do private practice in the way a medical professional does. But he is serving at a post where it is necessary to prohibit private practice...

The Union health ministry will soon amend Rule 26 of D&C Rules to mandate import license holders to maintain control samples of imported drugs so that circulation of spurious drugs can be verified and tracked effectively.  It is learnt that there is no such provision or condition available in the import license under the Drugs and Cosmetics (D&C) Rules, 1945. It becomes very difficult to verify the authenticity of spurious, misbranded or sub standard drugs found in the market as the control samples of these imported drugs are not available with the import license holder. Keeping patient safety into consideration, the Drugs Technical Advisory Board ( DTAB)  in its recent meet approved to include a provision in D&C Rules, 1945 for requirement of keeping the control samples of the drugs imported by the import license holder against the import license issued by Central Drugs Standard Control Organisation (CDSCO). Therefore, in order to remove this di...

The working pharmacists and regulatory officers across the country are planning to bring a proposal before the Drugs Consultative Committee (DCC) of the Union health ministry to make the registered pharmacists the sole authority to keep and sell medicines in the country. Their demand comes in the wake of the ministry's decision to amend D&C Rules to replace 'chemists & druggists' with 'pharmacy' to give retail trade a better professional recognition. They want the government to revoke Schedule K (5) in the D&C Act which mandates doctors to stock and 'supply' medicines to their own patients visiting their clinics or hospitals. The term 'supply' should be removed and the word, 'dispensing' should be inserted in the clause by specifying pharmacist's right to handle medicines even in clinics or hospitals run by medical professionals. In the next DCC meeting, expected to be held in May, the Drugs Controller of Odisha, Ma...

The Union health ministry will soon amend Rule 66 of Drugs and Cosmetics (D&C) Rules, 1940 to empower state drug controllers to issue stop sale order to drug wholesalers and retailers for non-compliance. Under Rule 66, currently state drug controllers cannot issue stop sale order on drug wholesalers and retailers for non-compliance as in the case of drug manufacturers on which the stop sale can be issued by the licensing authority without issuing show cause notice (SCN). As per Rule 66 currently, licensing authority can only suspend or cancel license after SCN has been served.  The licensing authority for manufacturing, as per Rule 85(2) of D&C Rules, are empowered to stop manufacturing, sale or distribution of the drug if in his/her opinion the licensee has failed to comply with any of the conditions of the license or with any provisions of the act or rules made thereunder. Therefore, the Union health ministry has considered the proposal floated at the 55th Drug Co...

In a move to boost the image of Indian drug manufacturers, the Central Drugs Standard Control Organisation (CDSCO) has for the first time released data of drugs declared as standard quality (SQ) by Central Drugs Laboratory (CDL) and Regional Drugs Testing Laboratories (RDTLs) along with monthly data of not of standard quality (NSQ) drugs. In a list of drugs, medical devices and cosmetics declared as not of standard quality, spurious, adulterated or misbranded, the CDSCO has revealed that for the month of March 2019, there were 2011 drug samples tested at four laboratories-- Central Drugs Laboratory (CDL), Kolkata, Central Drugs Testing Laboratory (CDTL), Mumbai, Regional Drugs Testing Laboratory (RDTL), Guwahati and Regional Drugs Testing Laboratory (RDTL), Chandigarh. Of them, 1,888 samples were found to be SQ and 50 samples were found to be NSQ. The data of SQ and NSQ drugs was released by CDSCO on April 15, 2019 after Union health and family welfare ministry h...

The Central Drugs Standard Control Organisation (CDSCO) has come out with an action plan to regulate all medical devices under Drugs and Cosmetics (D&C) Act in a phase wise manner to ensure safety, quality and performance of medical devices. This will also include diagnostic kits manufactured and imported in the country.  As of today, only 23 categories of medical devices are regulated under the provisions of D&C Act 1940 which cover around 400 medical devices amongst the 5,000 odd unregulated medical devices which pose risk to patient safety.  Many of the medical devices like equipment, analysers, instruments, etc. used in healthcare facilities for diagnosis, treatment and mitigation are currently out of the scope of regulation under D&C Act. The union health ministry had earlier constituted a committee on the issue. After detailed deliberations with different stakeholders, the committee has finally recommended that all medical devices should...