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Top Stories Pharmaceuticals

NEW FACILITY POLICY RETHINK

Coromandel inaugurates nano fertiliser plant in Kakinada Panel to examine if nutraceuticals and cosmetics

Agri-solutions provider, Coromandel can be produced within drug unit
International Ltd., has opened a
state-of-the-art nano fertiliser plant A fi ve-member expert committee It sought that such units be permitted to manufacturing which is fi nancially not
at its facility in Kakinada, Andhra will examine if manufacturing of nutra- manufacture cosmetics in the area dedi- viable,” it said. FoPE also noted that
Pradesh. The plant was unveiled by ceuticals and cosmetics should be cated for making topical products such entrepreneurs from 1988 till 2024 had
Mr. Sankarasubramanian S, the company’s allowed within drug manufacturing as external preparations such as creams no diffi culties or issues about quality
Executive Director (Nutrient Business), facilities. and lotions. for either drug or cosmetics products
in the presence of the company’s senior as necessary precautions including line
leadership and key channel partners The pharmaceutical industry had According to FoPE’s representa- clearance and preventing cross contami-
from across the nation. raised concerns regarding the govern- tion, the requirement as specifi ed in the nation were taken by the concerned
ment’s newly notifi ed Schedule M revised Schedule M has caused diffi - licensees. FoPE had asked the govern-
With this new facility, Coromandel that proposes a blanket ban on manu- culties to members which are medium ment to consider their request as cos-
has ventured into the new generation facture of any other article or product scale and small-scale pharmaceutical metic products are mostly in the form
of fertilisers, which have the potential apart from drugs in the units licensed entrepreneurs having well-equipped faci- of creams, suspensions, lotions that are
to revolutionise Indian agriculture, a for drug production. Following objec- lities with good manufacturing prac- like topical products such as creams,
company statement said. The fully tions raised by various pharma lobbies, tices. An exception was provided from and ointments. It also said that like
automated nano fertiliser plant has tre at IIT Bombay-Monash Research Coromandel markets its nano ferti- the Indian drug regulator has formed a the requirement that no manufacturing topical products, cosmetic products are
an annual production capacity of one crore Academy. “The government’s push for lisers under the ‘Gromor Nano’ brand committee to examine the issue. The activity shall be undertaken therein ex- also used externally, mostly for aesthetic
bottles. It is designed using energy-effi - Nano DAP marks a new era in Indian and has carried out extensive farmer committee comprises senior offi cials cept in respect of units licensed prior to purposes.
cient technologies and can be scaled up agriculture, where technology and sus- fi eld trials to establish their effi cacy. from the regulatory authority, experts 2001. In view of the aforesaid excep-
to manufacture multiple ranges of nano tainability go hand in hand. This inno- The fi rm has also set up a Nano Tech- from the National Institute of Pharma- tion, units licensed prior to 2001 were “Thus, there is a strong logical justi-
fertilisers besides the existing nano vative solution aligns with our goals of nology Centre at Coimbatore to focus ceutical Education and Research allowed to manufacture allied items fi cation for allowing cosmetic product
Di Ammonium Phosphate (DAP) and enhancing agricultural productivity and on nano applications in agriculture. (NIPER) and an industry expert. such as nutraceuticals and ayurvedic in Section dedicated for manufacture of
nano urea products. farm sustainability and we believe that medicines in the same plant. They were external preparation as by allowing it the
nano fertilisers will play a crucial role in Coromandel’s Kakinada unit has an Federation of Pharma Entrepre- also allowed to manufacture cosmetic cosmetic will be manufactured in much
Coromandel has developed these shaping the future of Indian agriculture,” annual production capacity of 2-million neurs (FoPE), a pharma lobby that products in the section meant for topi- more stringent good manufacturing
nano fertilisers, which ensure optimal commented Mr. Sankarasubramanian S, tonnes of conventional fertilisers cater- works with micro, small and medium cal products i.e. external preparations. practices requirement as compared to
nutrient delivery and absorption by Executive Director, Nutrient Business, ing to the requirements of the farming enterprises (MSMEs), had earlier said those specifi ed in Seventh Schedule of
plants, through its in-house R&D cen- Coromandel International. community across India. any clampdown in this regard will “However, some of them licensed the Cosmetics Rules, 2020,” the letter to
affect not only exports but also the prior to 2011 are engaged in the manu- the health secretary had said. Executives
MILESTONE domestic market. It had written to the facture of cosmetics in the external of FoPE had also met the health secre-
IPFT celebrates 34th Foundation Day health ministry citing that setting up products section. Now, in view of tary and the Drug Controller General of
a new plant exclusively for cosmetic revised Schedule M, they will have to set India (DCGI) seeking an exception to
The importance of biopesticides state-of-the-art user and environment Dr. Jitender Kumar, as well as industry manufacturing is fi nancially not viable. up a new plant exclusively for cosmetic select units as was given earlier.
and sustainable agriculture was one of friendly new generation pesticide formu- representatives, delegates from academic
the points stressed by speakers at the lation technologies, as well as their institutions and IPFT staff and students, Lupin recalls 51k bottles of generic antibiotic drug in US
34th Foundation Day celebrations of analysis, effi cacy and toxicity stud- also attended.
the Institute of Pesticides Formulation ies. Dignitaries who attended the event Lupin is recalling over 51,000 bot- rity,” US Food and Drug Administration Inc., it said. The drug maker initiated
Technology (IPFT), held on May 31, included Dr. U.S.N. Murty, Director, During the celebrations, IPFT has tles of a generic antibiotic medication (USFDA) said in its latest Enforcement the Class-II nationwide (US) voluntary
2024 at the Institute. NIPER Guwahati, Dr. D.S. Reddy, Di- released the revamped edition of its in the US market due to a “defective Report. The medicine is indicated for the recall on May 8 this year. As per the
rector, CSIR-IICT, Prof. Achanta Venu- magazine, and inaugurated an ‘Ad- container”, according to the American treatment of a range of bacterial infec- USFDA, a Class-II recall is initiated in
The IPFT is an autonomous Insti- gopal, CSIR-NPL, Prof. S.K. Mehta, vanced Equipment Facility’ at IPFT. health regulator. tions. a situation in which the use of, or expo-
tute under Department of Chemicals & Vice Chancellor, University of Ladakh, The IPFT and CSIR-Indian Institute of sure to, a violative product may cause
Petrochemicals, Ministry of Chemicals & Mr. Kuldeep Singh, CMD, Hindustan Petroleum (CSIR-IIP), Dehradun, also The company’s US subsidiary is re- The affected lot has been manu- temporary or medically reversible
Fertilizers, Government of India, and Insecticides Ltd., and Dr. Ramdev. The entered into a MoU to pursue colla- calling 51,006 bottles of Cefdinir for factured at Lupin’s Mandideep-based adverse health consequences or where
the only institute of its kind in the former IPFT directors, Ms. Neelkamal borative research to develop bio-for- Oral Suspension (250-mg/5-mL) due to plant and marketed in the US by Bal- the probability of serious adverse health
country devoted to the development of Darbari, IAS, Dr. S.K Raza and mulations through biomass utilisation. “defective container: lack of seal integ- timore-based Lupin Pharmaceuticals, consequences is remote.

140 Chemical Weekly June 18, 2024 Chemical Weekly June 18, 2024 141

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