The Gujarat Food and Drug Control Administration (FDCA) has issued hand sanitizer licenses to 515 manufacturers till date to address its growing demand amidst COVID-19 pandemic outbreak.
The state just had 15 hand sanitizer manufacturers before the first lockdown. Out of the 515 manufacturers, 135 are in the ayurvedic category, 270 manufacturers are under cosmetics category and 110 are under allopathic or drug category. “As a pre-emptive measure to ensure consistent supply of hand sanitizers, we have made the provision of approving licenses for hands sanitizers production and distribution under the emergency use authorization,” informs FDCA commissioner Dr HG Koshia.
The Gujarat government has also exempted sale and distribution of ethanol for production of hand sanitizers in order to tide over its shortage in the state. The exemption which was notified by the state government was done because the cost of isopropyl alcohol (IPA) which was Rs. 80 per litre earlier before the COVID-19 pandemic outbreak was being sold illegally at arbitrary price of Rs. 300 per litre. Gujarat has stock of 34 lakh hand sanitisers from the earlier 5 lakh sanitisers dated March 21, 2020.
Taking patient safety into consideration amidst outbreak of coronovirus pandemic, the Gujarat FDCA has approved product licences mostly from small and medium Indian manufacturers which have Schedule M compliant units and which are complying with the provisions of cosmetic rules.
A state level committee has also been formed to oversee the consistent supply of ARV drugs, masks and sanitisers. The committee is headed by Gujarat FDCA Commissioner Dr HG Koshia with members from the state industry department and state pollution control board. Union ministry of consumer affairs, food and public distribution has extended the validity of March 19, 2020 notification declaring hand sanitizer as essential commodity for six months until December 31, 2020 to ensure its continued availability at affordable price in the market.
Beside this, the ministry has also extended the validity of March 21 notification fixing the retail prices of hand sanitizer until December 31, 2020. As per the notification, the retail prices of hand sanitizer cannot be more than Rs. 100 per bottle of 200 ml. It is now capped at 100 ml at Rs 50 and 500 ml for Rs. 250. Both these notifications are in force till June 30, 2020.
The ministry in a notification on March 19, 2020 had brought raw materials for manufacture of hand sanitizer under Essential Commodities (EC) Act to ensure their smooth availability in market at affordable price in view of the outbreak of COVID-19.
The Gujarat Food and Drug Control Administration (FDCA) has issued licenses to 16 more plasma banks to maintain adequate convalescent plasma (CP) supply for Covid-19 management.
As of today, there are 28 functional plasma banks in the state of Gujarat.
The state regulator has also been urging the Drugs Controller General of India (DCGI) to encourage use of CP therapy in Covid-19 patients.
“CP therapy is safely administered on patients strictly on the supervision and prescription of the doctor. The condition of the patient is also considered while administering CP therapy. There is also demand for CP across the state but we are following the protocols and guidelines based on the fact that not every patient should be given CP. Besides this, there is no price control on CP which is why we are closely monitoring its supplies,” informed Gujarat FDCA Commissioner Dr H G Koshia.
As per the ICMR advisory, indiscriminate use of CP therapy is not advisable. It is speculated that CP having low concentration of specific antibodies against SARS-CoV-2 may be less beneficial for treating Covid-19 patients as compared to plasma with high concentration of such antibodies.
This advisory therefore embraces the principle that a potential donor for convalescent plasma should have sufficient concentration of antibody working against Covid-19 as narrated in the matrix below. It also highlights that presence of antibody against Covid-19 in a potential recipient makes transfusing convalescent plasma a futile intervention.
Based on ICMR PLACID trial conducted in 39 hospitals across the country, it was, however, concluded that CP therapy did not lead to reduction in progression to severe Covid-19 or all-cause mortality in the group that received CP therapy as compared to the group that did not receive CPT.
Based on the PLACID trial, the Central Government has also been considering removing CP therapy from the national clinical management protocol for Covid-19.
However, clinicians have contested that clinical trial studies to prove the efficacy of CP therapy are still ongoing and need some more time to arrive at the right conclusion in the interest of patient safety.
An evidence based advisory was also issued by the ICMR to the stakeholders to address inappropriate use of convalescent plasma in Covid-19 patients.
As per the ICMR advisory, CP therapy or passive immunotherapy has been tried in the past for treatment of viral infections like H1N11, Ebola and SARS-CoV-13 etc. Benefits of CPT in improving the clinical outcomes, reducing severity of disease, duration of hospitalization and mortality in Covid-19 patients are dependent on the concentration of specific antibodies in convalescent plasma that could neutralize the effects of SARS-CoV-2.
The appropriate age for CP donation is between 18 and 65 year three to seven days from onset of symptoms but not later than 10 days. There should be screening to rule out ABO incompatibility and blood borne pathogens such as HIV, HBV, HCV etc. There should be required concentration of IgG antibody against Covid-19 Titre of 1:640 (ELISA) or 13 AU (Absorbance Unit)/mL9 (CLIA) or Neutralising Antibody Titres of 1:80 (PRNT/MNT), as per the advisory.
The Gujarat Food and Drug Control Administration (FDCA) has issued licenses to total 610 pharma companies between April 1, 2020 and February 9, 2021 which include 312 pharma companies, 23 medical oxygen companies including 35 allopathic sanitizer companies under the Drugs and Cosmetics (D&C) Act, 1940.
The Gujarat FDCA had earlier approved licenses and layout plans of 240 pharma companies until 31st March, 2020.
Gujarat today boasts of over 700 plus WHO-GMP units and 130 US FDA approved drug manufacturing units in the country. Gujarat also has the distinction of having 28 per cent of drug exports to developed markets including the US. The Gujarat pharmaceutical industry is also upbeat as around 900 out of 1,100 plants had started operations in the state despite lockdown. Most of these plants produce formulations.
“These 900 plants represent major companies like Alembic, Sun Pharma, Intas, Troikaa Pharma among others,” informed Gujarat FDCA Commissioner Dr HG Koshia.
Some of the major companies to start operations based on the layout design approvals of plants are Exotic Pharma, Godhara; Aashka Formulation, Gandhinagar; Akshar Air Gases, Surat; Swan Medicot Morbid, Fishfa Biogenics, Rajkot; Chevron Pharma, Bharuch; Alidac Pharmaceuticals, Ahmedabad Rural; Madilyn Healthcare, Ahmedabad Rural; M J Healthcare, Mehsana, Labron Healthcare, Mehsana; Trio Lifescience, Ahmedabad city; Punishka Healthcare, Edkem Pharmaceuticals, Avantika Medex, Derek Healthcare, Dewcare Concept, Afeel Life Care; Rajkot and Moksh Pharmaceuticals, Vadodara.
The environment is conducive for development of pharmaceutical industry as Gujarat government has also revised its time line for grant of manufacturing licenses to 60 days from the earlier stipulated time line of 120 days.
Revision of timeliness for grant of manufacturing licenses has been a major initiative of the government as part of Pharma Vision 2020 under the Right of Citizens to Services for speedy issuance of licenses.
The Gujarat government was first state government which exempted sale and distribution of ethanol for production of hand sanitisers in order to tide over the shortage of hand sanitisers in the state.
Hand sanitizer was brought under the ambit of essential commodities and subsequent price control to regulate its illegal sale in the unorganized market.