Nicaragua becomes first Spanish-speaking nation to recognize Indian Pharmacopoeia

In a significant diplomatic development, Nicaragua has become the first Spanish-speaking nation to officially recognize the Indian Pharmacopoeia (IP) or Indian Pharma standards. This development follows the signing of a Memorandum of Understanding (MoU) on Pharmacopoeia Cooperation between the governments of India and Nicaragua.

The ceremony, held in Nicaragua's capital, saw the signing of the MoU by Dr Sumit Seth, the Indian Ambassador to Nicaragua, and Dr Martha Reyes, Nicaragua's Minister of Health.

The Memorandum of Understanding underscores a shared commitment to collaboration in the regulation of medicines, marking a crucial step towards international harmonization of pharmaceutical standards.

The move is expected to foster stronger ties between the two nations in the areas of healthcare, encouraging the exchange of expertise and resources for improved medical standards.

The Indian Pharmacopoeia (IP), compiled by the Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare in India, serves as the official compendium of standards for drugs.

With the latest edition published in 2022, the IP comprises over 3,000 monographs, establishing precise limits and testing methods for both raw materials and finished pharmaceutical products.

The legal significance of the IP within India, enshrined in the Second Schedule of the Drugs & Cosmetics Act, 1940, necessitates adherence to its standards for all imported, manufactured, and distributed drugs within the country.

This recognition by Nicaragua adds another feather to the IP's cap, solidifying its global standing and influence.

The IPC, an autonomous institute with the mandate to publish the IP at regular intervals has created a key document as a benchmark for pharmaceutical standards.

The IP's recognition by Nicaragua follows suit with five other countries - Afghanistan, Ghana, Nepal, Mauritius, and Suriname - who have already acknowledged its importance in ensuring the quality and safety of medicinal products.

The formal recognition of the Indian Pharmacopoeia serves as a testament to the growing importance of standardized regulations in the global pharmaceutical landscape.

UP Released Pharma & Medical Devices Industry Policy, 2023

The Uttar Pradesh government has issued the Pharmaceutical and Medical Devices Industry Policy, 2023, which includes provisions for a single window clearance under the direct supervision of the Chief Minister's office, time-bound clearances, pre-consultation of project plans by the regulator, and a dedicated technical advisory body for guidance and support, in addition to incentives for pharma parks, manufacturing units, and support for start-ups and marketing activities.

The State will have a single window clearance system, which will be directly supervised by the Chief Minister's office, as part of its efforts to promote ease of doing business.

The regulations will ensure timely delivery of services, clearances, permissions, and permits as part of making time bound clearances.

The Food and Drug Administration (FSDA) will appoint a nodal officer to help investors in obtaining the pollution No Objection Certificate (NOC) and other certificates required to develop pharmaceutical facilities.

The FSDA team will review the project dossier and building plan supplied by the investors to determine the feasibility of the project, and a Letter of Comfort will be issued to the investor following satisfactory scrutiny of the dossier.

The government will also set up the Uttar Pradesh Pharmaceutical Development Cell (UPPDC) as an advisory body for technical guidance and support.

The cell will be chaired by the Additional Chief Secretary or Principal Secretary of the Department of FSDA and consist of representatives from concerned departments and experts from different areas of pharmaceutical and biotechnology, while representatives from the industry associations will be invited members. The matter referred by the regulatory committees and others will be taken up by the Cell from time to time and it will also facilitate the development of a data bank and resource centres apart from other supports.

There will also be an Empowered Committee, chaired by the Chief Secretary, to oversee the policy's development and the scheme's implementation. It would also have the jurisdiction to approve proposals for mega projects (projects with a capital investment of more than Rs. 100 crore). Representatives from industry associations will also be invited members.

The policy aims to revamp the State's pharmaceutical and medical device industry by encouraging local production, promoting research and development and improving the availability of affordable medicines to the citizens.

The policy focuses on creating a conducive environment for the growth of the pharmaceutical industry in the state aiming to attract investments in the sector by providing a range of incentives such as subsidies and land allocation for setting up manufacturing units.

It also intends to create a robust ecosystem for research and development by setting up State-of-the-art facilities and collaborating with academic institutions and research institutes.

Around 217 companies have proposed to invest nearly Rs. 28,500 crore in the pharmaceutical and medical devices sector. These investments are expected to create nearly 57,000 job opportunities, boost the local economy, and contribute to the growth of the sector. The State also has a robust manpower availability for the industry, it added.

CDSCO Suspended Manufacturing of Eye Drops of Global Pharma, Chennai

India's Central Drugs Standard Control Organization (CDSCO) has suspended the manufacturing of eye drops at the Chennai-based firm after US FDA allegedly linked 55 adverse events cases with contaminated eye drops.

The samples were taken for analysis from four batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium was also taken: Sources on 'Artificial Tears' eyedrops

The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of the investigation

During the investigation by senior drug inspectors, it was found that Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of 'Artificial Tears' to USA which were manufactured in 2021 and 2022

Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears.

6 months jail if TDS on Free Samples to Doctors not Deposited

The Union Government has recently clarified that failing to deduct and pay 10 percent TDS on the value of freebies received by doctors, as required under Section 194R (TDS on benefit or perquisite in respect of business or profession) in the Income-tax Act, 1961, will attract jail term for up to 6 months and a sum of penalty.

This came during the budget for the year 2023-24, wherein, various amendments have been proposed for the taxpayers by the Union Finance Minister Nirmala Sitharaman.

Last year, the Central Board of Direct Taxes (CBDT) had issued the guidelines clarifying the applicability of the newly inserted section 194R in the Income-tax Act, 1961 effective July 1, 2022.

The new section 194R mandates a person, who is responsible for providing any benefit or perquisite to a resident, to deduct tax at source @ 10% of the value or aggregate of value of such benefit or perquisite, before providing such benefit or perquisite. The benefit or perquisite may or may not be convertible into money but should arise either from carrying out of business, or from exercising a profession, by such resident.

However, the provisions for penalty and prosecution did not clearly mandated penalty or prosecution for a person who does not pay or fails to ensure compliance to the said Section.

To ensure highest level of compliance and adherence to Section 194R, lately, the Government has proposed to amend section 271C and section 276B of the Act by incorporating penalty and prosecution provisions pursuant to non-adherence of Section 194R (TDS on benefit or perquisite in respect of business or profession) effective from the 1st day of April, 2023.

With this, all Assessess need to be vigilant and cannot take these provisions lightly.

Section 271C is proposed to be amended to state that where a person fails to pay or ensure payment as required under Section 194R, then Section 271C which is a penalty provision, can get attracted.

Further, Section 276B refers to prosecution and corresponding amendments for non-compliance of Section 194R and Section 194S have been proposed in prosecution provisions as well.

After section 276A of the Income-tax Act, the following section shall be inserted, namely: —

"276B. If a person, without reasonable cause or excuse, fails to deduct or after deducting fails to pay the tax as required by or under the provisions of sub-section (9) of section 80E or Chapter XVII-B, he shall be punishable with rigorous imprisonment for a term which may extend to six months, and shall also be liable to fine which shall be not less than a sum calculated at the rate of fifteen per cent, per annum on the amount of such tax from the date on which such tax was deductible to the date on which such tax is actually paid."

The move is going to cast a severe dent on the traditional pharma marketing practices across the country. The applicability of the new provision is likely to make handing out of freebies and even free samples to doctors less attractive, which comes as a major setback for pharma companies.

Medical Dialogues team had earlier reported that the new Finance Budget had clarified that any claims of expenses incurred while providing benefits to others that violate the provisions of Indian Medical Council Regulations, 2002 shall be inadmissible for a tax deduction. With this, pharma companies can no longer claim such expenditure as a business deduction, which in turn will jack up the taxable profits of a pharma company. The Government has also been considering to make the UCPMP mandatory for all pharmaceutical companies.

Zero observations of USFDA for Gland Pharma's Visakhapatnam facility

Gland Pharma said that the United States Food and Drug Administration (US FDA) had conducted an inspection at the company's API Facility at JNPC, Visakhapatnam, from 23rd January 2023 to 27th January 2023.

The drug maker further informed that the said inspection has been completed with 'zero' observations.

Hyderabad-based Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

The pharmaceutical company's consolidated net profit dropped 15% to Rs 231.95 crore on 11.8% decline in net sales to Rs 938.29 crore in Q3 FY23 over Q3 FY22.

The scrip had advanced 1.16% to end at Rs 1357.10 on the BSE on Friday.