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.

Labeling Norms For Generic Drugs Changed: Health Minister

The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey through a written reply in the Lok Sabha informed about the labeling norms for generic drugs.

In order to ensure that the consumer is well informed about the generic medicine, Ministry of Health and Family Welfare published a draft notification for public comments vide GSR 302 (E) dated 30.03.2017 for amendment of Rule 96 to provide that the proper name of the drugs shall be printed in a conspicuous manner which shall be in the same font but at level two font size larger than the brand name or the trade name, if any. It will come to force after completion of due formalities as per the provisions of the Drugs and Cosmetics Act, 1940.

Indian Drug Manufacturers Association (IDMA) was invited to the stakeholders meeting held on 12.12.2017 in Central Drugs Standard Control Organisation (CDSCO) and they conveyed their inability to attend the meeting. However, they had already provided their suggestions/ comments on the draft notification vide letter dated, 11.05.2017 which has been received in the Ministry.

#Natco Pharma seeks #USFDA Approval for #Hepatitis Drug

Drug firm Natco Pharma said it has filed an abbreviated new drug application (ANDA) for Sofosbuvir Tablets, 400mg, with the United States Food and Drug Administration (USFDA).

Sofosbuvir is used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc, under its brand Sovaldi, Natco Pharma said in a filing to BSE.

The company believes that “they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval,” it added.

For the 12 months ending December 31, 2017, Sovaldi had US sales of approximately USD 130 million as per Gilead Sciences Inc’s unaudited results released for the year ending December 31, 2017, Natco Pharma said.

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